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Food and Drug Administration – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of over 3,100
| Document | Doc Number | Type | Agency | |
|---|---|---|---|---|
| November 6, 2009 | ||||
| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 57491–57493 [E9–26760] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0507] Agency Information Collection Activities: Proposed Collection; Comment Request;
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format 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 | 57495–57496 [E9–26850] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0506] Agency Information Collection Activities; Proposed Collection; Comment Request;
Bar Code Label Requirement for Human 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. Under the Paperwork Reduction Act... [read document] |
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| Guidance for Industry and Food and Drug Administration Staff: In Vitro Diagnostic 2009 H1N1 Tests for Use in 2009 H1N1 Emergency; Availability | 57503–57504 [E9–26737] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0319] Guidance for Industry and Food and Drug Administration Staff; In Vitro
Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA) is announcing the availability of the guidance entitled ``In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency.'' FDA is issuing... [read document] |
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| November 5, 2009 | ||||
| Listing of Color Additives Exempt From Certification: Astaxanthin Dimethyldisuccinate | 57248–57251 [E9–26524] | Rule | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No. FDA-2007-C-0044] (formerly Docket No. 2007C-0474) Listing of Color Additives
Exempt From Certification; Astaxanthin Dimethyldisuccinate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is
amending the color additive regulations to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish... [read document] |
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| Amendment to Memorandum of Understanding: Food and Drug Administration and WebMD, LLC | 57316–57318 [E9–26674] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0667] [FDA-2008-N-0043] Amendment to Memorandum of Understanding Between the Food and
Drug Administration and WebMD, LLC AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is providing notice of an amendment
to a memorandum of understanding (MOU) between FDA's Office of External Relations and WebMD, LLC. DATES: The amendment became effective October... [read document] |
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| Food and Drug Administration's Safe Use Initiative; Availability of Information | 57319–57320 [E9–26530] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0526] Food and Drug Administration's Safe Use Initiative; Availability of Information
AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the launch of its Safe Use Initiative with the release
of a report titled ``FDA's Safe Use Initiative--Collaborating to Reduce Preventable Harm from Medicines.'' FDA is opening a docket to enable the... [read document] |
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| Amendment to Memorandum of Understanding: Dosage Delivery Devices for Over-The-Counter Liquid Drug Products; Availability | 57319 [E9–26531] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0322] Draft Guidance for Industry on Dosage Delivery Devices for Over- The-Counter
Liquid Drug 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 titled ``Dosage Delivery Devices for OTC Liquid Drug Products.'' FDA is issuing this guidance because of ongoing... [read document] |
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| November 4, 2009 | ||||
| Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes; Extension of Comment Period | 57179–57180 [E9–26636] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0346] Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of
Tomatoes; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is
extending to January 4, 2010, the comment period for the draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food... [read document] |
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| Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons; Extension of Comment Period | 57179 [E9–26638] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0347] Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of
Melons; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is
extending to January 4, 2010, the comment period for the draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety... [read document] |
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| Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Extension of Comment Period | 57180 [E9–26637] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0348] Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of
Leafy Greens; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration (FDA)
is extending to January 4, 2010, the comment period for the draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food... [read document] |
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| November 3, 2009 | ||||
| Draft Guidance for Industry on Listing of Ingredients in Tobacco Products; Availability | 56842–56843 [E9–26466] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0524] Draft Guidance for Industry on Listing of Ingredients in Tobacco 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 ``Listing of Ingredients in Tobacco Products.'' The draft guidance document is intended to assist persons making tobacco product... [read document] |
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| Meetings: Product Tracing Systems for Food | 56843–56855 [E9–26479] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0523] Product Tracing Systems for Food; Public Meeting AGENCY: Food and Drug
Administration, HHS. ACTION: Notice; request for comment. SUMMARY: The Food and Drug Administration (FDA), in collaboration with the United States Department of Agriculture,
Food Safety and Inspection Service (FSIS), is announcing a public meeting regarding product tracing systems for food intended for humans and animals. The... [read document] |
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| Meetings: International Conference on Harmonisation S2 Genetic Toxicology Issues; Request for Comments | 56856–56857 [E9–26397] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0519] Public Workshop: International Conference on Harmonisation S2 Genetic
Toxicology Issues; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. SUMMARY: The Food and Drug
Administration (FDA) is announcing a public workshop entitled ``ICH S2 Genetic Toxicology Issues.'' The 1-day public workshop is intended to seek constructive input...
[read document] |
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| November 2, 2009 | ||||
| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 56642–56643 [E9–26307] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0360] Agency Information Collection Activities; Submission for Office of Management
and Budget Review; Comment Request; Food and Drug Administration Public Health Notification Readership Survey (Formerly Known as ``Safety Alert/Public Health Advisory Readership
Survey'') AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 56643–56644 [E9–26290] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0497] Agency Information Collection Activities; Proposed Collection; Comment Request;
Abbreviated New Animal Drug Applications 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), Federal... [read document] |
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| Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information | 56644–56649 [E9–26291] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0521] Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied
by Emergency Use Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the issuance
of an Emergency Use Authorization (EUA) (the Authorization) for peramivir 200 milligrams (mg)/20 milliliter (mL) (10 mg/mL) single use vial... [read document] |
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| Meetings: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee | 56650–56651 [E9–26259] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Gastroenterology and Urology 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: Gastroenterology and Urology Devices Panel of the Medical... [read document] |
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| Meetings: Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee | 56651–56652 [E9–26260] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Ear, Nose, and Throat 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: Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory... [read document] |
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| Meetings: Pediatric Advisory Committee; Amendment | 56652 [E9–26262] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2009-N-0664] Pediatric Advisory Committee; Amendment of Notice AGENCY: Food and Drug
Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting
was announced in the Federal Register of October 6, 2009 (74 FR 51289). The amendment is being made to reflect a change in the Agenda portion of the... [read document] |
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| Meetings: Neurological Devices Panel of the Medical Devices Advisory Committee; Postponement | 56655 [E9–26261] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of
Postponement of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of the Neurological
Devices Panel of the Medical Devices Advisory Committee scheduled for November 20, 2009. This meeting was announced in the Federal Register of... [read document] |
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| October 29, 2009 | ||||
| Investigational New Drug Applications; Technical Amendment | 55770–55771 [E9–26095] | Rule | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 312 [Docket No. FDA-2009-N-0464] Investigational New Drug Applications; Technical Amendment
AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending its investigational new drug
application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for... [read document] |
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| October 28, 2009 | ||||
| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 55556–55557 [E9–25915] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0511] Agency Information Collection Activities; Proposed Collection; Comment Request;
Medicated Feed Mill License Application 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), Federal... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 55557–55558 [E9–25927] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0215] Agency Information Collection Activities; Submission for Office of Management
and Budget Review; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water 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... [read document] |
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| Draft Guidance for Industry and Reviewers: Structured Product Labeling Standard for Content of Labeling Technical Questions and Answers, Revision | 55562–55564 [E9–25940] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0355] Draft Guidance for Industry and Reviewers on Structured Product Labeling
Standard for Content of Labeling Technical Questions and Answers, Revision; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug
Administration (FDA) is announcing the availability of a draft revised guidance for industry and reviewers entitled ``SPL Standard for Content of... [read document] |
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| Draft Guidance for Industry and Reviewers: Science Advisory Board to the National Center for Toxicological Research | 55564–55565 [E9–25941] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Science Advisory Board to the National Center for Toxicological Research 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: Science Advisory Board (SAB) to the National... [read document] |
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| October 27, 2009 | ||||
| Meetings: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee | 55243 [E9–25806] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Pediatric Oncology Subcommittee of the Oncologic 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: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory... [read document] |
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| Meetings: Endocrinologic and Metabolic Drugs Advisory Committee | 55243–55244 [E9–25805] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] 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).
The meeting will be open to the public. Name of Committee: Endocrinologic and Metabolic Drugs Advisory Committee. General Function of the Committee: To... [read document] |
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| Public Workshop: Emerging Arboviruses; Risk Assessment for Blood, Cell, Tissue, and Organ Safety | 55244–55245 [E9–25802] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue, and Organ
Safety; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing a public workshop
entitled ``Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue and Organ Safety.'' The purpose of the public workshop is to assess the risk and... [read document] |
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| Prescription Drug User Fee Rates for Fiscal Year 2010; Correction | 55244 [E9–25804] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0339] Prescription Drug User Fee Rates for Fiscal Year 2010; 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 August 3,
2009 (74 FR 38451). The document announced the fiscal year 2010 fee rates for the Prescription Drug User Fee Act. The document was published with... [read document] |
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| Public Workshop: Request for Safety and Effectiveness Data; Withdrawal | 55245–55246 [E9–25803] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0063] (formerly Docket No. 2004N-0346) Saccharomyces boulardii Eligibility for
Consideration To Be Added to the Over-the-Counter Drug Monograph for Antidiarrheal Drug Products; Request for Safety and Effectiveness Data; Withdrawal AGENCY: Food and Drug
Administration, HHS. ACTION: Withdrawal of notice of eligibility and request for data and information. SUMMARY: We (Food and Drug Administration (FDA))... [read document] |
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| October 26, 2009 | ||||
| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 55046–55048 [E9–25671] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0512] Agency Information Collection Activities; Proposed Collection; Comment Request;
Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008 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... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 55050–55051 [E9–25604] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0496] Agency Information Collection Activities; Proposed Collection; Comment Request;
Tobacco Product Standard for Flavored Cigarettes 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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| Guidance for Industry on Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects; Availability | 55052–55053 [E9–25629] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0307 (formerly Docket No. 2007-D-0173)] Guidance for Industry on Investigator
Responsibilities-- Protecting the Rights, Safety, and Welfare of Study Subjects; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and
Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Investigator Responsibilities--Protecting the Rights,... [read document] |
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| Guidance for Industry on Investigator Responsibilities: Anti-Infective Drugs Advisory Committee | 55056–55057 [E9–25627] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] 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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| Guidance for Industry on Investigator Responsibilities: | 55057 [E9–25628] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] 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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| October 23, 2009 | ||||
| New Animal Drug Applications | 54749–54751 [E9–25517] | Rule | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 [Docket No. FDA-2009-N-0436] New Animal Drug Applications AGENCY: Food and Drug
Administration, HHS. ACTION: Direct final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the regulations regarding new animal drug applications (NADAs).
Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission.... [read document] |
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| New Animal Drug Applications | 54771–54773 [E9–25518] | Proposed Rule | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 [Docket No. FDA-2009-N-0436] New Animal Drug Applications AGENCY: Food and Drug
Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to amend the regulations regarding new animal drug applications (NADAs).
Specifically, this proposed rule is being issued to provide that NADAs shall be submitted in the form and containing the information described, as... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 54824–54826 [E9–25539] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0480] Agency Information Collection Activities; Proposed Collection; Comment Request;
Investigational Device Exemptions Reports and Records 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... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 54826–54827 [E9–25538] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0486] Agency Information Collection Activities; Proposed Collection; Comment Request;
Guidance for Industry, FDA, and Foreign Governments: Fiscal Year 2010 Medical Device User Fee Small Business Qualification and Certification 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... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 54827–54829 [E9–25537] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0505] Agency Information Collection Activities; Proposed Collection; Comment Request;
Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle 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... [read document] |
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| October 22, 2009 | ||||
| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 54570–54571 [E9–25395] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0474] Agency Information Collection Activities; Proposed Collection; Comment Request;
Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 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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| Meetings: Radiological Devices Panel of the Medical Devices Advisory Committee | 54583 [E9–25406] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Radiological 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: Radiological Devices Panel of the Medical Devices Advisory Committee. General... [read document] |
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| Meetings: Nonvoting Industry Representatives on Public Advisory Committees, et al. | 54589–54590 [E9–25407] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Request for Notification From Industry Organizations Interested in
Participating in Selection Process for Nonvoting Industry Representatives on Public Advisory Committees and Request for Nominations for Nonvoting Industry Representatives on
Public Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is requesting that any... [read document] |
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| October 20, 2009 | ||||
| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 53743–53746 [E9–25102] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0296] Agency Information Collection Activities; Submission for Office of Management
and Budget Review; Comment Request; Food Labeling 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 | 53746–53749 [E9–25100] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0501] Agency Information Collection Activities; Proposed Collection; Comment Request;
Third Party Disclosure and Recordkeeping Requirements for Reportable Food 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... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 53749–53750 [E9–25178] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0487] Agency Information Collection Activities; Proposed Collection; Comment Request;
Guidance on Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable 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... [read document] |
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| Agency Information Collection Activities; Proposals, Submissions, and Approvals | 53750–53751 [E9–25177] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0489] Agency Information Collection Activities; Proposed Collection; Comment Request;
Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications 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... [read document] |
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| Draft Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood, etc. | 53751–53752 [E9–25136] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0490] Draft Guidance for Industry and Food and Drug Administration Staff:
Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified
Indications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the... [read document] |
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| Draft Guidance for Industry and Food and Drug Administration Staff: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications | 53753–53754 [E9–25135] | Notice | Food and Drug Administration | |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0157] (Formerly Docket No. 2006D-0514) Guidance for Industry: Minimally Manipulated,
Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications; Availability AGENCY: Food and Drug Administration, HHS.
ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for... [read document] |
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| Web Location of 2010 Proposed Guidance Development | 53754–53755 [E9–25179] | 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] Medical Device User Fee and Modernization Act; Notice to Public of Web Location
of 2010 Proposed Guidance Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the Web location
where it will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In... [read document] |
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