Comprehensive List of Guidance Documents at the Food and Drug Administration, 48180-48233 [2010-19342]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 75, Number 152 (Monday, August 9, 2010)]
[Notices]
[Pages 48180-48233]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19342]



[[Page 48179]]

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Part III





Department of Health and Human Services





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Food and Drug Administration



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Comprehensive List of Guidance Documents at the Food and Drug 
Administration; Notice

Federal Register / Vol. 75, No. 152 / Monday, August 9, 2010 / 
Notices

[[Page 48180]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1998-N-0050] (formerly Docket No. 1998N-0046)


Comprehensive List of Guidance Documents at the Food and Drug 
Administration

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is publishing a 
comprehensive list of all guidance documents currently in use at the 
agency. This list is being published under FDA's Good Guidance 
Practices (GGPs). It is intended to inform the public of the existence 
and availability of all of our current guidance documents. It also 
provides information on guidance documents that have been added or 
withdrawn in the past 5 years.

DATES:  We welcome general comments on this list and on agency guidance 
documents at any time.

ADDRESSES:  Submit electronic comments to https://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.
    For information on a specific guidance or to obtain a paper copy, 
please refer to each Center's section of this document.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's GGPs were published in the Federal Register of September 19, 
2000 (65 FR 56468), and became effective October 19, 2000. GGPs (21 CFR 
10.115) are intended to ensure involvement of the public in the 
development of guidance documents, and to enhance understanding of the 
availability, nature, and legal effect of such guidance.
    FDA has adopted a new format for the publication of its 
comprehensive guidance list. This new format is intended to increase 
the timeliness of the comprehensive list. For information on a specific 
guidance or to obtain a paper copy, please refer to each Center's 
section of this document. The lists of guidance documents are either a 
printout of FDA's Web site as of April 2010 or a list compiled by the 
issuing office. You should note that some guidance documents pertain to 
more than one product area (e.g., drugs and biologics), and are, 
therefore, listed under both Centers involved or pertain to more than 
one subject matter (e.g., ``Food Defense and Emergency Response'' and 
``Imports''), and are, therefore, listed under more than one category 
within a Center. So there may be some duplication in the guidance 
lists. You are encouraged to use FDA's Web site as the most up-to-date 
source for all current guidance documents in use by the agency, as the 
Web site is updated on a daily basis.
    In accordance with the agency's general policy on guidances, you 
may comment on this list and on any FDA guidance document at any time.
    We have organized the guidance documents by the issuing Center or 
Office within FDA. The dates in the list refer to the date we issued 
the guidances or, where applicable, the last date we revised a 
document. Because each issuing Center or Office maintains its own 
database, there are slight variations in the way in which they provide 
the information.

II. Center for Biologics Evaluation and Research (CBER)

    For information a specific guidance document or to obtain a paper 
copy, contact:
    Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-
1800, e-mail: ocod@fda.hhs.gov, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    The following is a list of CBER guidance documents that have been 
withdrawn:

------------------------------------------------------------------------
                                              Date of         Date of
            Title of Document                 Issuance      Withdrawal
------------------------------------------------------------------------
Guidance for Industry: Gamma Irradiation   3/15/2000      4/10/2006
 of Blood and Blood Components: A Pilot
 Program for Licensing
------------------------------------------------------------------------
Draft Guidance for Industry: CBER Pilot    7/11/2001      4/11/2006
 Licensing Program for Immunization of
 Source Plasma Donors Using Immunogen Red
 Blood Cells Obtained from an Outside
 Supplier
------------------------------------------------------------------------
Draft Guidance for Industry: Submitting    8/23/2001      August 9,
 Type V Drug Master Files to the Center                    2010.
 for Biologics Evaluation and Research
------------------------------------------------------------------------

    The following list of current CBER guidance documents was obtained 
from FDA's Web site on April 20, 2010:

Administrative
   Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments,
   and Proposed REMS Modifications (PDF - 316KB)
   9/2009
   Formal Meetings Between the FDA and Sponsors or Applicants (PDF - 89KB)
   5/2009
   Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific
   Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
   1/2009
   Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties - Manufacturer's Notification of
   the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section
   228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
   9/15/2005

[[Page 48181]]

 
   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria
   10/4/2004
   Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions
   (510(k)s)
   5/28/2004
   FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock
   and Performance Assessment
   5/21/2004
   Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
   11/24/2003
   Premarket Approval Application Modular Review
   11/3/2003
Adverse Events and Product Deviation Guidances
   Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs--Improving
   Human Subject Protection (PDF - 61KB)
   1/2009
   Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an
   Influenza Pandemic (PDF - 246KB)
   12/2008
   Providing Regulatory Submissions in Electronic Format--Postmarketing Individual Case Safety Reports
   (PDF - 107KB)
   6/2008
   Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of
   Biological Products Other than Blood and Blood Components
   10/2006
   Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products--Content
   and Format (PDF - 52KB)
   1/2006
   Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF -
   375KB)
   3/2001
   Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products:
   Clarification of What to Report (PDF - 95KB)
   8/1997
Allergenic Guidance Documents
   Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts
   11/20/2008
   Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A
   Revised Protocol
   11/20/2000
   Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information
   and Establishment Description Information for an Allergenic Extract or Allergen Patch Test
   4/23/1999
Application Submissions
   Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug
   Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB)
   2/2010
   SPL Standard for Content of Labeling Technical Qs & As (PDF - 58KB)
   10/2009
   Investigator Responsibilities--Protecting the Rights, Safety, and Welfare of Study Subjects (PDF -
   163KB)
   10/2009
   Providing Regulatory Submissions in Electronic Format--(PDF - 123KB)
   5/2009
   Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) -
   The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
   12/2008
   Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
   11/2008
   Tropical Disease Priority Review Vouchers (PDF - 112KB)
   10/2008
   Integrated Summary of Effectiveness (PDF - 95KB)
   8/2008
   Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA
   Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (PDF Version) (PDF - 121KB)
   8/2008
   Providing Regulatory Submissions in Electronic Format--Postmarketing Individual Case Safety Reports
   (PDF - 107KB)
   6/2008
   Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and
   Related Submissions Using the eCTD Specifications (PDF - 133KB)
   6/2008
   Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications
   (PMAs): Effect on FDA Review Clock and Goals (PDF Version) (PDF - 155KB)
   6/2008
   Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s,
   Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF Version) (PDF - 103KB)
   2/2008
   Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF
   Version) (PDF - 127KB)
   2/2008
   Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and
   Research (CBER) in Electronic Format - Lot Release Protocols (PDF - 76KB)
   11/2007

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   In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions (PDF - 268KB)
   10/2007
   Pharmacogenomic Data Submissions--Companion Guidance (PDF - 211KB)
   8/2007
   Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single
   Submission (PDF Version) (PDF - 145KB)
   6/2007
   Providing Regulatory Submissions in Electronic Format--Receipt Date (PDF - 59KB)
   6/2007
   Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval
   Applications (PMA) (PDF Version) (PDF - 127KB)
   10/2006
   Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF
   Version) (PDF - 82KB)
   4/2006
   Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130 of the Food
   and Drug Administration Modernization Act of 1997 (PDF - 456KB)
   2/2006
   Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF
   - 295KB)
   2/2006
   Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF -
   110KB)
   2/2006
   Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB)
   2/2006
   How to Comply with the Pediatric Research Equity Act (PDF - 116KB)
   9/2005
   Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
   5/2005
   Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software
   Contained in Medical Devices (PDF version) (PDF - 342KB)
   5/2005
   Providing Regulatory Submissions in Electronic Format--Content of Labeling (PDF - 28KB)
   4/2005
   Good Review Management Principles and Practices for PDUFA Products (PDF - 683KB)
   4/2005
   Pharmacogenomic Data Submissions (PDF - 96KB)
   3/2005
   Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF
   - 211KB)
   12/2004
   Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical
   Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB)
   11/2004
   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria (PDF Version) (PDF - 175KB)
   10/2004
   Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions
   (510(k)s) (PDF Version) (PDF - 109KB)
   5/2004
   Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k))
   Submissions: Effect on FDA Review Clock and Performance Assessment (PDF Version) (PDF - 515KB)
   5/2004
   Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications (PDF
   Version) (PDF - 87KB)
   11/2003
   Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF
   - 159KB)
   11/2003
   Providing Regulatory Submissions in Electronic Format - General Considerations (PDF - 288KB)
   10/2003
   Part 11, Electronic Records; Electronic Signatures--Scope and Application (PDF - 215KB)
   8/2003
   Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF Version) (PDF
    529KB)
   5/2003
   Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement
   Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
   2/2003
   Comparability Protocols--Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
   2/2003
   Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA
   Staff - PDF (PDF - 548KB)
   2/2003
   Special Protocol Assessment (PDF - 36KB)
   5/2002
   Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format--Investigational
   New Drug Applications (INDs) (PDF) (PDF - 80KB)
   3/2002
   Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
   10/2001
   Draft Guidance for Industry - Submitting Type V Drug Master Files to the Center for Biologics
   Evaluation and Research
   9/2001

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   Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF -
   50KB)
   8/2001
   Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (PDF -
   32KB)
   4/2001
   Acceptance of Foreign Clinical Studies (PDF - 12KB)
   3/2001
   Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
   11/2000
   Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
   10/2000
   Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic,
   Biotechnology-Derived Products (PDF - 14KB)
   10/2000
   Formal Meetings With Sponsors and Applicants for PDUFA Products (PDF - 30KB)
   2/2000
   Formal Dispute Resolution: Appeals Above the Division Level (PDF - 30KB)
   2/2000
   Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act
   (PDF - 57KB)
   9/1999
   Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (PDF - 43KB)
   8/1999
   Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in
   Electronic Format - Biologics Marketing Applications (PDF - 582KB)
   11/1999
   Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory
   Committees (PDF - 62KB)
   10/1998
   Submitting Debarment Certification Statements (PDF - 144KB)
   9/1998
   Standards for Prompt Review of Efficacy Supplements (PDF - 76KB)
   5/1998
   Classifying Resubmissions in Response to Action Letters (PDF - 76KB)
   4/1998
   Pediatric Use Supplements--Content and Format (PDF - 24KB)
   5/1996
   Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs (PDF
    41KB)
   11/1995
   Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs,
   Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
   11/1995
   FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and
   Manufacture of Biological Products; Availability (PDF - 34KB)
   7/1995
   Submission Documentation for Sterilization Process Validation in Applications for Human and
   Veterinary Drug Products (PDF - 57KB)
   11/1994
   Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB)
   3/1991
   Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance
   with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration
   Amendments Act of 2007
Blood Guidance Documents
   Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood
   Components, October 2009 (PDF - 858KB)
   10/2009, Updated: 12/2009
   Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood
   Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus (PDF - 80KB)
   11/13/2009
   Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile
   Virus from Donors of Whole Blood and Blood Components Intended for Transfusion (PDF - 68KB)
   11/6/2009
   Draft Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for
   Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
   Reconstitution for Specified Indications (PDF - 91KB)
   10/2009
   Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
   Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 462KB)
   10/2009
   Guidance for Industry - Recommendations for Management of Donors at Increased Risk for Human
   Immunodeficiency Virus Type 1 (HIV-1) Group O Infection
   8/2009
   Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19
   Transmission by Plasma-Derived Products
   7/28/2009
   Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of
   Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and
   Cellular and Tissue-Based Products
   3/2009
   Assay Migration Studies for In Vitro Diagnostic Devices
   1/5/2009

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   Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune
   Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
   7/17/2008
   Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of
   Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)
   5/20/2008
   Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West
   Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human
   Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   4/25/2008
   Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods
   12/17/2007
   Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood
   Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
   11/29/2007
   Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B
   Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source
   Plasma and Source Leukocytes
   11/21/2007
   Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility
   10/26/2007
   Guidance for Industry: ``Lookback'' for Hepatitis C Virus (HCV): Product Quarantine, Consignee
   Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor
   Test Results Indicating Infection with HCV
   8/24/2007
   Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance
   Genotype Assay
   8/08/2007
   Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in
   Plasmapheresis and Immunization Programs
   6/20/2007
   Draft Guidance for Industry: ``Computer Crossmatch'' (Electronic Based Testing for the Compatibility
   between the Donor's Cell Type and the Recipient's Serum or Plasma Type)
   6/20/2007
   Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and
   Accompanying Materials for Use in Screening Donors of Blood and Blood Components
   10/27/2006
   Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
   10/18/2006
   Guidance for Industry: Bar Code Label Requirements - Questions and Answers
   10/5/2006
   Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component
   Container Labels
   9/22/2006
   United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components
   Using ISBT 128 (PDF - 1665KB)
   9/22/2006
   Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-
   Associated and Other Immunoglobulin (IgG) Antibodies
   8/08/2006
   Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to
   ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of
   Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products''
   8/08/2006
   Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-
   1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
   7/19/2005
   Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of
   Known or Suspected West Nile Virus Infection
   6/23/2005
   Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor
   Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-
   Based Products (HCT[sol]Ps)
   11/24/2004
   Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
   11/30/2004
   Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as
   Red Blood Cell Substitutes
   10/28/2004
   Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of
   Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and
   Appropriately Reduce the Risk of Transmission of HIV-1 and HCV
   10/21/2004
   Questions and Answers on ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible
   Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood
   and Blood Products''
   1/22/2004
   Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of
   West Nile Virus - Guidance for Industry and FDA Staff
   10/30/2003
   Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion
   9/22/2003
   Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood
   Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS
   9/16/2003

[[Page 48185]]

 
   Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-
   Administered Questionnaires
   7/3/2003
   Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on
   Screening Tests for Syphilis
   6/25/2003
   Question and Answer on FDA Guidance Entitled ``Recommendations for the Assessment of Donor
   Suitability and Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory
   Syndrome (SARS) or Exposure to SARS''
   4/25/2003
   Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product
   Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS
   4/17/2003
   Questions and Answers on FDA Guidance Entitled ``Recommendations for Deferral of Donors and
   Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia
   Virus) and Certain Contacts of Smallpox Vaccine Recipients''
   1/15/2003
   Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood
   and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox
   Vaccine Recipients
   12/30/2002
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts
   2/1/2002
   General Principles of Software Validation; Final Guidance for Industry and FDA Staff
   1/11/2002
   Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of
   Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
   1/9/2002
   Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices
   11/22/2001
   Guidance for Industry - Recommendations for Assessment of Donor Suitability and Blood and Blood
   Product Safety in Cases of Possible Exposure to Anthrax
   10/17/2001
   Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary
   Hemochromatosis
   8/22/2001
   Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood
   Components Intended for Transfusion or for Further Manufacture
   8/07/2001
   Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers
   7/19/2001
   Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile
   Connecting Devices)
   7/19/2001
   Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the
   Collection and Processing of Blood and Blood Components
   7/19/2001
   Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and
   510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
   7/11/2001
   Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing
   3/29/2001
   Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods
    Technical Correction February 2001
   2/13/2001
   Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components
   Intended for Transfusion
   1/23/2001
   Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric
   Blood Specimens
   6/23/2000
   Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to
   Malaria
   6/8/2000
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts
   12/23/1999
   Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic
   Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2
   12/14/1999
   Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug
   Regulations (PDF - 26KB)
   7/15/1999
   Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured
   for Commercial Use
   5/20/1999
   Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products
   5/20/1999
   Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment
   Description Information for Human Blood and Blood Components Intended for Transfusion or for Further
   Manufacture and For the Completion of the Form FDA 356h ``Application to Market a New Drug, Biologic or an
   Antibiotic Drug for Human Use''
   5/10/1999
   Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and
   Establishment Description Information for a Biological In Vitro Diagnostic Product
   3/8/1999

[[Page 48186]]

 
   Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment
   Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products
   2/17/1999
   Withdrawal of ``Guidance for Industry: Supplemental Testing and the Notification of Consignees of
   Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)''
   9/8/1998
   Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral
   Marker Testing
   6/11/1998
   Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results
   for Antibody to Hepatitis C Virus (Anti-HCV)
   3/20/1998
   Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in
   the Manufacture of Blood Products
   1/08/1998
   Guidance for Industry: Donor Screening for Antibodies to HTLV-II
   8/15/1997
   Guidance for Industry: Changes to an Approved Application: Biological Products (PDF - 39KB)
   7/1997
   Guideline for Quality Assurance in Blood Establishments (PDF - 77KB)
   7/11/1995
   Draft Recommended Methods for Blood Grouping Reagents Evaluation (PDF - 2101KB)
   3/1992
   Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin
   (PDF - 1161KB)
   3/1992
   Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents
   and Anti-Human Globulin (PDF - 211KB)
   1992
   Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious
   Disease Markers (``High Risk'' Donors) (PDF - 176KB)
   10/26/1989
   Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect
   Antibodies to the Human Immunodeficiency Virus Type 1 (PDF - 1784KB)
   8/08/1989
   Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For
   Human and Animal Parenteral Drugs, Biological Products and Medical Devices (PDF - 2874KB)
   12/1987
   Guideline for the Uniform Labeling of Blood and Blood Components (PDF - 1189KB)
   8/1985
   Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances (PDF - 368KB)
   6/1980
Cellular & Gene Therapy Guidance Documents
   Draft Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for
   Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
   Reconstitution for Specified Indications (PDF - 91KB)
   10/2009
   Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
   Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 462KB)
   10/2009
   Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
   9/2009
   Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
   09/2009
   Draft Guidance for Industry: Somatic Cell Therapy for Cardiac Disease
   03/2009
   Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products
   10/9/2008
   Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control
   (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
   4/9/2008
   Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control
   (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
   4/9/2008
   Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility
   Testing of Cellular and Gene Therapy Products
   2/11/2008
   Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and
   Tissue-Based Products
   8/8/2007
   Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace
   Knee Cartilage
   7/6/2007
   Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events
   11/28/2006
   Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in
   Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using
   Retroviral Vectors
   11/28/2006
   Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy
   3/30/1998

[[Page 48187]]

 
   Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment
   Description for Autologous Somatic Cell Therapy Products (TXT - 59KB)
   01/1997
CMC & GMP
   Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug
   Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB)
   2/2010
   Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (PDF - 91KB)
   11/2008
   Process Validation: General Principles and Practices (PDF - 194KB)
   11/2008
   Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 132KB)
   7/2008
   Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using
   Spore-Forming Microorganisms (PDF - 184KB)
   9/6/2007
   Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF -
   443KB)
   9/2006
   Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF
    253KB)
   9/2006
   Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF -
   110KB)
   1/2006
   Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
   5/2005
   Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice (PDF -
   734KB)
   9/2004
   Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing,
   and Controls Information (PDF - 82KB)
   9/2003
   Comparability Protocols--Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
   2/2003
   CVM GFI 153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use
   in Humans and Animals (PDF - 88KB)
   9/2002
   Container Closure Systems for Packaging Human Drugs and Biologics--Questions and Answers (PDF - 15KB)
   5/2002
   IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF -
   30KB)
   5/2001
   Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 30KB)
   3/2001
   Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation
   (PDF - 91KB)
   8/2000
   Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8KB)
   8/1999
   Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB)
   5/1999
   Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB)
   7/1998
   Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150KB)
   3/1998
   Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a
   Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (PDF - 44KB)
   8/1996
   Submission Documentation for Sterilization Process Validation in Applications for Human and
   Veterinary Drug Products (PDF - 57KB)
   11/1994
   Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For
   Human and Animal Parenteral Drugs, Biological Products and Medical Devices (PDF - 2874KB)
   12/1987
   Guidance on Alternatives to Lot Release for Licensed Biological Products (PDF - 305KB)
   7/14/1993
Clinical
   Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB)
   7/2009
   Postmarketing Studies and Clinical Trials--Implementation of Section 505(o) of the Federal Food,
   Drug, and Cosmetic Act (PDF - 173KB)
   7/2009
   The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug
   Application (PDF - 421KB)
   6/2009
   Animal Models--Essential Elements to Address Efficacy Under the Animal Rule (PDF - 135KB)
   2/2009
   Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs--Improving
   Human Subject Protection (PDF - 61KB)
   1/2009
   Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 145KB)
   5/2007
   Computerized Systems Used in Clinical Trials (PDF - 53KB)
   5/2007

[[Page 48188]]

 
   Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF
    253KB)
   9/2006
   Chronic Cutaneous Ulcer and Burn Wounds--Developing Products for Treatment (PDF - 205KB)
   6/2006
   Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens
   that are Not Individually Identifiable (PDF Version) (PDF - 65KB)
   4/25/2006
   The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial
   Sponsors
   3/2006
   Using a Centralized IRB Review Process in Multicenter Clinical Trials (PDF - 87KB)
   3/2006
   Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130 of the Food
   and Drug Administration Modernization Act of 1997 (PDF - 456KB)
   2/2006
   Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and
   Format (PDF - 127KB)
   2/2006
   Collection of Race and Ethnicity Data in Clinical Trials (PDF - 70KB)
   9/2005
   Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult
   Healthy Volunteers (PDF - 702KB)
   7/2005
   Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF - 3151KB)
   4/2005
   Premarketing Risk Assessment (PDF - 88KB)
   3/2005
   Development and Use of Risk Minimization Action Plans (PDF - 225KB)
   3/2005
   Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220KB)
   3/2005
   Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF -
   363KB)
   2/2005
   Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF
   - 211KB)
   12/2004
   Available Therapy (PDF - 176KB)
   7/2004
   Vaccinia Virus--Developing Drugs to Mitigate Complications from Smallpox Vaccination (PDF - 139KB)
   3/2004
   Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF -
   40KB)
   1/2004
   IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of
   Cancer (PDF - 188KB)
   1/2004
   Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF Version)
   (PDF - 389KB)
   7/2003
   Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact
   on Dosing and Labeling (PDF - 222KB)
   5/2003
   Exposure-Response Relationships--Study Design, Data Analysis, and Regulatory Applications (PDF -
   221KB)
   4/2003
   Establishing Pregnancy Exposure Registries (PDF - 268KB)
   8/2002
   Special Protocol Assessment (PDF - 36KB)
   5/2002
   FDA Guidance on Clinical Trial Data Monitoring Committees (DMC's) Open Public Meeting (PDF - 394KB)
   11/2001
   Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
   10/2001
   IDE Financial Disclosure
   Acceptance of Foreign Clinical Studies (PDF - 12KB)
   3/2001
   Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
   11/2000
   Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
   10/2000
   Pediatric Oncology Studies In Response to a Written Request (PDF - 30KB)
   6/2000
   In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations
   for Dosing and Labeling (PDF - 44KB)
   11/2009
   Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment
   of Osteoarthritis (PDF - 40KB)
   7/1999
   Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of
   Rheumatoid Arthritis (RA) (PDF - 369KB)
   2/1999
   Population Pharmacokinetics (PDF - 135KB)
   2/1999
   FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (PDF - 58KB)
   12/1998

[[Page 48189]]

 
   General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (PDF -
   37KB)
   11/1998
   Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF - 129KB)
   5/1998
   Pharmacokinetics in Patients with Impaired Renal Function (PDF - 128KB)
   5/1998
   Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs,
   Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
   11/1995
Devices
   Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version) (PDF -
   388KB)
   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria (PDF Version) (PDF - 175KB)
   Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions
   (510(k)s) (PDF Version) (PDF - 109KB)
   Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and
   Biological Products (PDF - 112KB)
   Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) -
   The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
   Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) -
   The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
   Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications
   (PMAs): Effect on FDA Review Clock and Goals (PDF Version) (PDF - 155KB)
   Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and
   Answers (PDF Version) (PDF - 196KB)
   Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s,
   Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF Version) (PDF - 103KB)
   Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF
   Version) (PDF - 127KB)
   In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions (PDF - 268KB)
   Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF Version)
   (PDF - 139KB)
   In Vitro Diagnostic Multivariate Index Assays (PDF version) (PDF - 72KB)
   Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single
   Submission (PDF Version) (PDF - 145KB)
   Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval
   Applications (PMA) (PDF Version) (PDF - 127KB)
   Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software
   Contained in Medical Devices (PDF version) (PDF - 342KB)
   Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and
   Format (PDF - 127KB)
   Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens
   that are Not Individually Identifiable (PDF Version) (PDF - 65KB)
   Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF
   Version) (PDF - 82KB)
   Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
   Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical
   Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB)
   Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF Version)
   (PDF - 389KB)
   Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k))
   Submissions: Effect on FDA Review Clock and Performance Assessment (PDF Version) (PDF - 515KB)
   Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF
   - 159KB)
   Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF Version) (PDF
    529KB)
   Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement
   Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
   Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA
   Staff - PDF (PDF - 548KB)
   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria (PDF Version) (PDF - 175KB)
Labeling & Promotion
   Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug
   and Biological Products (PDF - 163KB)
   Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
   Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF
   - 295KB)
   Labeling for Human Prescription Drug and Biological Products--Determining Established Pharmacologic
   Class for Use in the Highlights of Prescribing Information (PDF - 65KB)
   Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 387KB)
   Indexing Structured Product Labeling (PDF - 59KB)
   Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF Version)
   (PDF - 139KB)
   Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products--Content
   and Format (PDF - 52KB)
   Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and
   Format (PDF - 127KB)
   Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human
   Prescription Drug and Biological Products--Content and Format (PDF - 58KB)
   Labeling for Human Prescription Drug and Biological Products--Implementing the New Content and Format
   Requirements (PDF - 213KB)
   Providing Regulatory Submissions in Electronic Format--Content of Labeling (PDF - 28KB)
   Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF -
   363KB)
   Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic
   Devices Intended for Professional Use (PDF Version) (PDF - 1385KB)
   Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (PDF - 192KB)
   ``Help-Seeking'' and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms
   (PDF - 188KB)
   Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact
   on Dosing and Labeling (PDF - 222KB)

[[Page 48190]]

 
   Content and Format for Geriatric Labeling (PDF - 38KB)
   Prescription Drug Advertising and Promotional Labeling (PDF - 28KB)
   In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations
   for Dosing and Labeling (PDF - 44KB)
   Consumer-Directed Broadcast Advertisements (PDF - 36KB)
   Accelerated Approval Products--Submission of Promotional Materials (PDF - 17KB)
   Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 86KB)
   Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 -
   Elimination of Certain Labeling Requirements (PDF - 979KB)
Tissue Guidance Documents
   Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of
   Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and
   Cellular and Tissue-Based Products
   3/2009
   Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for
   Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   1/16/2009
   Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
   (HCT[sol]Ps) - Small Entity Compliance Guide
   8/24/2007
   Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace
   Knee Cartilage
   7/6/2007
   Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update
   9/20/2006
   Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for
   Transplantation
   3/8/2002
   Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West
   Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human
   Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   4/25/2008
   Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products
   (HCT[sol]Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or
   Diagnostic Tests
   4/16/2008
   Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and
   Tissue-Based Products
   8/8/2007
   Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor
   Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-
   Based Products (HCT[sol]Ps)
   11/12/2004
   Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric
   Blood Specimens
   6/23/2000
   Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1)--Manufacturing Arrangements
   9/8/2006
   Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to
   Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   11/30/2005
   Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally
   Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
   7/23/2007
   Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and
   Storage Container
   1/31/2007
   Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord
   Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
   1/16/2007
   Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation
   (PDF - 59KB)
Vaccine Guidance Documents
   Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological
   Materials Used in the Production of Viral Vaccines for Infectious Disease Indications (PDF - 406KB)
   3/2010
   Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
   09/2009
   Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global
   Infectious Diseases
   9/8/2008
   Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
   10/29/2007
   Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in
   Preventive Vaccine Clinical Trials
   9/27/2007
   Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
   5/31/2007
   Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated
   Influenza Vaccines
   5/31/2007
   Draft Guidance for Industry: Characterization and Qualification of Cell Substrates and Other
   Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of
   Infectious Diseases
   9/28/2006
   Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
   5/4/2006
   Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and
   Therapeutic Vaccines for Infectious Disease Indications
   2/13/2006

[[Page 48191]]

 
   Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease
   Indications
   2/17/2005
   Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions,
   and Precautionary Information
   10/1/2004
   Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products
   Including Vaccines
   3/12/2001
   Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A
   Revised Protocol
   11/20/2000
   Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines
   for Infectious Disease Indications
   9/8/2000
   Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and
   Establishment Description Information for a Vaccine or Related Product
   1/5/1999
   Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1) (PDF
   - 63KB)
   9/8/1998
   Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases:
   Production, Testing and Clinical Studies (PDF - 49KB)
   4/10/1997
Xenotransplantation Guidance Documents
   Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of
   Xenotransplantation Products in Humans
   4/3/2003
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts
   2/1/2002
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts
   12/23/1999
   PHS Guideline on Infectious Disease Issues in Xenotransplantation
   1/19/2001
   Guidance For Industry: Public Health Issues Posed by the Use of Non-Human Primate Xenografts in
   Humans
   4/6/1999
 

III. Center for Drug Evaluation and Research (CDER)

    For information on a specific guidance document or to obtain a 
paper copy, contact:
    Division of Drug Information, Office of Training and 
Communications, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver 
Spring, MD 20993, 1-888-463-6332 or 301-796-3400, e-mail: 
druginfo@fda.hhs.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm.
    The following list of withdrawn CDER guidance documents was 
obtained from FDA's Web site on April 21, 2010:

----------------------------------------------------------------------------------------------------------------
                                                               Level at Date     Publication/
                  Title                         Subject          of Issue       Withdrawal Date       Status
----------------------------------------------------------------------------------------------------------------
Continuous Marketing Applications: Pilot  Procedural          Level 1         04/09/2010          Withdrawn
 1--Reviewable Units for Fast Track
 Products under PDUFA
----------------------------------------------------------------------------------------------------------------
Continuous Marketing Applications: Pilot  Procedural          Level 1         04/09/2010          Withdrawn
 2--Scientific Feedback and Interactions
 during Development of Fast Track
 Products under PDUFA
----------------------------------------------------------------------------------------------------------------
Continuous Marketing Applications: Pilot  Procedural          Level 1         04/09/2010          Withdrawn
 2--Scientific Feedback and Interactions
 during Development of Fast Track
 Products under PDUFA; Paperwork
 Reduction Act Burden Statement
----------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Lipid-Altering     Clinical Medical    Level 1         04/16/2010          Withdrawn
 Agents                                    Draft
----------------------------------------------------------------------------------------------------------------

    The following list of current CDER guidance documents was obtained 
from FDA's Web site on April 21, 2010:

------------------------------------------------------------------------
                                                                 Issue
                  Title and Format                      Type      Date
------------------------------------------------------------------------
Advertising
Accelerated Approval Products: Submission of          Draft    3/26/1999
 Promotional Materials (PDF - 17 KB)
Aerosol Steroid Product Safety Information in         Final    12/1997
 Prescription Drug Advertising and Promotional
 Labeling (PDF - 84 KB)
Brief Summary: Disclosing Risk Information in         Draft    2/4/2004
 Consumer-Directed Print Advertisements (PDF - 192
 KB)
   Labeling Example (PDF - 105 KB)            .......  .........
   Labeling Example; Consumer-Friendly        .......  .........
   Version (PDF - 95KB)

[[Page 48192]]

 
Consumer-Directed Broadcast Advertisements (PDF -     Final    8/1999
 36KB)
Questions and Answers (PDF - 83 KB)
Consumer-Directed Broadcast Advertising of            Draft    1/26/2004
 Restricted Devices (PDF - 41 KB)
``Help-Seeking'' and Other Disease Awareness          Draft    1/26/2004
 Communications by or on Behalf of Drug and Device
 Firms (PDF - 188 KB)
Industry-Supported Scientific and Educational         Final    12/3/1997
 Activities (PDF - 429 KB)
Presenting Risk Information in Prescription Drug and  Draft    5/26/2009
 Medical Device Promotion (PDF - 387 KB)
Product Name Placement, Size, and Prominence in       Draft    1/1999
 Advertising and Promotional Labeling (PDF - 86KB)
Biopharmaceutics
Bioanalytical Method Validation (PDF - 63 KB)         Final    5/2001
Bioavailability and Bioequivalence Studies for Nasal  Draft    4/2/2003
 Aerosols and Nasal Sprays for Local Action (PDF -             4/11/2003
 519 KB)
   Statistical Information from the June      .......  .........
   1999 Draft Guidance and Statistical Information
   for In Vitro Bioequivalence Data (PDF - 186 KB)
Bioavailability and Bioequivalence Studies for        Final    3/2003
 Orally Administered Drug Products - General
 Considerations (PDF - 268 KB)
Cholestyramine Powder in Vitro Bioequivalence (PDF -  Final    7/15/93
 35 KB) (Intermin Guidance)
Clozapine Tablets: In Vivo Bioequivalence and In      Final    6/17/2005
 Vitro Dissolution Testing (PDF - 78 KB)
Conjugated Estrogens, USP-LC-MS Method for Both       Draft    8/12/2005
 Qualitative Chemical Characterization and            Withdra
 Documentation of Qualitative Pharmaceutical           wn
 Equivalence.                                         FR
                                                       Notice
Corticosteroids, Dermatologic (topical) In Vivo (PDF  Final    6/2/1995
 - 3 MB) (Issued 6/2/1995, Posted 3/6/1998)
Dissolution Testing of Immediate Release Solid Oral   Final    8/1997
 Dosage Forms (PDF - 130 KB) (Issued 8/1997, Posted
 8/25/1997)
Extended Release Oral Dosage Forms: Development,      Final    9/1997
 Evaluation, and Application of In Vitro/In Vivo
 Correlations (PDF - 170 KB)
Food-Effect Bioavailability and Fed Bioequivalence    Final    12/2002
 Studies(PDF - 166 KB)
Metaproterenol Sulfate and Albuterol Metered Dose     Final    6/27/1989
 Inhalers I