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Food and Drug Administration – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of over 2,400
| Document | Doc Number | Type | Agency | |
|---|---|---|---|---|
| October 10, 2008 | ||||
| Meetings: Cardiovascular and Renal Drugs Advisory Committee | 60299–60300 [E8–24199] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0038] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY:
Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The
meeting will be open to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide... [read document] |
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| Meetings: Anti-Infective Drugs Advisory Committee | 60299 [E8–24197] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0038] Anti-Infective Drugs Advisory Committee; Notice of Meeting AGENCY: Food and
Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will
be open to the public. Name of Committee: Anti-Infective Drugs Advisory Committee. General Function of the Committee: To provide advice and... [read document] |
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| Meetings: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee | 60300–60301 [E8–24163] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0038] General and Plastic Surgery Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food
and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical... [read document] |
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| October 9, 2008 | ||||
| Distribution of Certain Drug Products by Registered Blood Establishments and Comprehensive Hemophilia Diagnostic Treatment Centers | 59496–59501 [E8–24050] | Rule | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 203 and 205 [Docket No. FDA-2005-N-0345] (formerly Docket No. 2005N-0428) Distribution of
Certain Drug Products by Registered Blood Establishments and Comprehensive Hemophilia Diagnostic Treatment Centers That Qualify as Health Care Entities; Prescription Drug
Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures AGENCY: Food and Drug Administration, HHS.... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 59633–59634 [E8–23910] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0314] Agency Information Collection Activities; Submission for Office of Management
and Budget Review; Comment Request; Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing
that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 59633 [E8–23907] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0128] (formerly Docket No. 1999D-2013) Agency Information Collection Activities;
Announcement of Office of Management and Budget Approval; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics AGENCY: Food and Drug
Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for... [read document] |
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| Meetings: Science Board | 59634–59635 [E8–24051] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0038] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY:
Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The
meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the... [read document] |
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| Potency Tests for Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability | 59635–59636 [E8–24052] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0520] Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy
Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft
document entitled ``Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products'' dated October 2008. The draft guidance document provides... [read document] |
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| October 7, 2008 | ||||
| Meetings: Endocrinologic and Metabolic Drugs Advisory Committee; Correction | 58603–58604 [E8–23718] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0038] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting;
Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration is correcting a notice that appeared in the Federal
Register of September 24, 2008 (73 FR 55114). The document announced a forthcoming meeting of a public advisory committee of the Food and Drug... [read document] |
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| Anitox; Filing of Food Additive Petition (Animal Use); Formaldehyde | 58603 [E8–23723] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-F-0518] Anitox; Filing of Food Additive Petition (Animal Use); Formaldehyde AGENCY:
Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that Anitox has filed a petition proposing that the food
additive regulations be amended to provide for the safe use of formaldehyde to retard the growth of Clostridium perfringens in animal feeds. DATES: Submit... [read document] |
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| Pilot Program To Evaluate Proposed Name Submissions; Concept Paper | 58604–58605 [E8–23715] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0281] Pilot Program To Evaluate Proposed Name Submissions; Concept Paper AGENCY: Food
and Drug Administration, HHS. ACTION: Notice; availability. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a concept paper entitled ``PDUFA
Pilot Project Proprietary Name Review.'' The concept paper provides information to pharmaceutical firms about how to evaluate proposed propriety... [read document] |
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| New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products; Draft Guidance for Industry | 58604 [E8–23712] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0525] Draft Guidance for Industry on New Contrast Imaging Indication Considerations
for Devices and Approved Drug and Biological Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is
announcing the availability of a draft guidance for industry entitled ``New Contrast Imaging Indication Considerations for Devices and Approved... [read document] |
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| Withdrawal of Approval of 128 Suitability Petitions; Correction | 58606 [E8–23721] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-P-0474] (formerly Docket No. 2004P-0262) Withdrawal of Approval of 128 Suitability
Petitions; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared
in the Federal Register of February 23, 2007 (72 FR 8184). The notice announced that FDA was withdrawing approval of 128 suitability petitions in... [read document] |
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| October 6, 2008 | ||||
| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 58248 [E8–23606] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-N-0098] (formerly Docket No. 2005N-0349) Agency Information Collection Activities;
Announcement of Office of Management and Budget Approval; Survey of Current Manufacturing Practices in the Food Industry AGENCY: Food and Drug Administration, HHS. ACTION:
Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Survey of Current Manufacturing... [read document] |
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| October 1, 2008 | ||||
| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 57106–57108 [E8–22989] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0499] Agency Information Collection Activities; Proposed Collection; Comment Request;
Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The
Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 57108–57109 [E8–22991] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0512] Agency Information Collection Activities; Proposed Collection; Comment Request;
Medical Devices: Humanitarian Use Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity
for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA),... [read document] |
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| Determinations: ATROVENT (Ipatropium Bromide) Inhalation Solution et al. Not Withdrawn for Reasons of Safety or Effectiveness | 57109–57111 [E8–23035] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0506] Determination That ATROVENT (Ipatropium Bromide) Inhalation Solution and 10
Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug
Administration (FDA) has determined that the 11 drug products listed in this document were not withdrawn from sale for reasons of safety or... [read document] |
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| Determinations: Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Correction | 57111–57112 [E8–23120] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0484] Preparation for International Conference on Harmonization Meetings in Brussels,
Belgium; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting; correction. SUMMARY: The Food and Drug Administration (FDA) is
announcing a correction to the notice of a public meeting entitled ``Preparation for International Conference on Harmonization Meetings in Brussels,... [read document] |
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| Determinations: Food and Drug Administration, the National Cancer Institute, a Part of the National Institutes of Health, and the CRIX International Association | 57112–57122 [E8–22992] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0043] [FDA No. 225-08-8004] Memorandum of Agreement Between the Food and Drug
Administration, the National Cancer Institute, a Part of the National Institutes of Health, and the CRIX International Association AGENCY: Food and Drug Administration, HHS.
ACTION: Notice. SUMMARY: The Food and Drug Administration FDA) is providing notice of a memorandum of agreement (MOA) between FDA, the National Cancer... [read document] |
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| September 30, 2008 | ||||
| Medical Device User Fee and Modernization Act: Web Location of 2009 Proposed Guidance Development | 56830–56831 [E8–22911] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-N-0270] (formerly Docket No. 2007N-0357) Medical Device User Fee and Modernization Act;
Notice to Public of Web Location of 2009 Proposed Guidance Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)
is announcing the Web location where the agency will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is... [read document] |
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| Medical Device User Fee and Modernization Act: Antiviral Drugs Advisory Committee | 56831 [E8–22912] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0038] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug
Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion
of the meeting will be closed to the public. Name of Committee: Antiviral Drugs Advisory Committee. General Function of the Committee: To provide... [read document] |
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| September 29, 2008 | ||||
| Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis | 56477–56487 [E8–22730] | Rule | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2004-P-0205] (formerly Docket No. 2004P-0464) Food Labeling: Health Claims;
Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA)
is amending its labeling regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to include... [read document] |
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| Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports: Reporting Information About Authorized Generic Drugs | 56487–56491 [E8–22833] | Rule | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 314 [Docket No. FDA-2008-N-0341] Applications for Food and Drug Administration Approval to
Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule. SUMMARY: The
Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information... [read document] |
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| Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports: Reporting Information About Authorized Generic Drugs; Companion Document to Direct Final Rule | 56529–56533 [E8–22829] | Proposed Rule | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 314 [Docket No. FDA-2008-N-0341] Applications for Food and Drug Administration Approval to
Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs; Companion Document to Direct Final Rule AGENCY: Food and Drug Administration,
HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule,... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 56592–56595 [E8–22731] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0500] Agency Information Collection Activities; Proposed Collection; Comment Request;
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food
and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency.... [read document] |
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| September 26, 2008 | ||||
| Draft Guidance for Industry on End-of-Phase 2A Meetings; Availability | 55851–55852 [E8–22669] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0514] Draft Guidance for Industry on End-of-Phase 2A Meetings; Availability AGENCY:
Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled
``End-of-Phase 2A Meetings.'' This draft guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug... [read document] |
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| Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications | 55852–55853 [E8–22668] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2008-M-0207, FDA-2008-M-0243, FDA-2008-M-0244, FDA- 2008-M-0283, FDA-2008-M-0335,
FDA-2008-M-0311, FDA-2008-M-0342, FDA- 2008-M-0378] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug
Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that... [read document] |
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| September 25, 2008 | ||||
| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 55516–55517 [E8–22636] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0272] Agency Information Collection Activities; Submission for Office of Management
and Budget Review; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body AGENCY: Food and Drug
Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been... [read document] |
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| September 24, 2008 | ||||
| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 55108–55111 [E8–22435] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0240] Agency Information Collection Activities; Submission for Office of Management
and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals AGENCY: Food and Drug Administration, HHS. ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 55111–55114 [E8–22440] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0077] Agency Information Collection Activities; Submission for Office of Management
and Budget Review; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and... [read document] |
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| Meetings: Endocrinologic and Metabolic Drugs Advisory Committee | 55114–55115 [E8–22437] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0038] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).
At least one portion of the meeting will be closed to the public. Name of Committee: Endocrinologic and Metabolic Drugs Advisory Committee. General... [read document] |
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| Meetings: Product Tracing Systems for Fresh Produce | 55115–55122 [E8–22430] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0513] Product Tracing Systems for Fresh Produce; Public Meetings AGENCY: Food and
Drug Administration, HHS. ACTION: Notice of public meeting; request for comment. SUMMARY: The Food and Drug Administration (FDA) is announcing two public meetings regarding
product tracing systems for fresh produce. The purpose of the meetings is to stimulate and focus a discussion about mechanisms to enhance product... [read document] |
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| September 23, 2008 | ||||
| Enforcement Action Dates: Ophthalmic Balanced Salt Solutions for Ocular Surgical Procedures | 54829–54831 [E8–22305] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0482] Ophthalmic Balanced Salt Solutions for Ocular Surgical Procedures; Enforcement
Action Dates AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing its intention to take enforcement action
against unapproved ophthalmic balanced salt solutions for irrigation of the eye during surgery and persons\1\ who manufacture or cause the... [read document] |
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| Enforcement Action Dates: Topical Drug Products Containing Papain | 54831–54834 [E8–22300] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0481] Topical Drug Products Containing Papain; Enforcement Action Dates AGENCY: Food
and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved topical
drug products containing papain and persons\1\ who manufacture or cause the manufacture of such products or their shipment in interstate commerce.... [read document] |
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| September 22, 2008 | ||||
| Global Harmonization Task Force, Study Groups 1 and 5; Proposed and Final Documents; Availability; Correction | 54600 [E8–22094] | Notice | Food and Drug Administration | |
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0372] Global Harmonization Ta | ||||