Agency: Food and Drug Administration
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[FR Doc E9-175] 276. Agency Information Collection Activities; Submission for Office of Management
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 Paperwork Reduction Act of 1995.
Published: 2009-01-09 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-213] 277. Agency Information Collection Activities; Proposed Collection; Comment
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 agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each
Published: 2009-01-09 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-155] 278. International Conference on Harmonisation; Guidance on Q4B Evaluation and
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter.'' The guidance was prepared under the auspices of the International Conference on
Published: 2009-01-09 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-214] 279. International Conference on Harmonisation; Guidance on Q4B Evaluation and
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter.'' The guidance was prepared under the auspices of the International Conference on
Published: 2009-01-09 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-108] 280. Agency Information Collection Activities; Submission for Office of Management
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 Paperwork Reduction Act of 1995.
Published: 2009-01-08 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-31253] 281. Listing of Color Additives Exempt From Certification; Food, Drug, and
The Food and Drug Administration (FDA) is revising its requirements for cochineal extract and carmine by requiring their declaration by name on the label of all food and cosmetic products that contain these color additives. This final rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract containing food
Published: 2009-01-05 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-31319] 282. Draft Guidance for Industry and Food and Drug Administration Staff; Assay
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Assay Migration Studies for In Vitro Diagnostic Devices.'' This draft guidance presents a least burdensome regulatory approach to gaining FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously
Published: 2009-01-05 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-31321] 283. Guidance for Industry on Labeling Over-the-Counter Human Drug
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling OTC Human Drug ProductsQuestions and Answers.'' This guidance is intended to assist manufacturers, packers, and distributors of overthecounter (OTC) drug products in complying with the agency's regulation on standardized content
Published: 2009-01-05 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-31249] 284. ``Guidance for Industry: Substantiation for Dietary Supplement Claims Made
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.'' The guidance describes the amount, type, and quality of evidence that FDA recommends a manufacturer have to
Published: 2009-01-05 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-31248] 285. Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and
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 Committees: Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
General Function of the Committees: To provide
Published: 2009-01-05 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-31320] 286. Training Program for Regulatory Project Managers; Information Available to
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact
Published: 2009-01-05 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-31213] 287. Medical Devices; Immunology and Microbiology Devices; Classification of
The Food and Drug Administration (FDA) is classifying enterovirus nucleic acid assay into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA'' (ribonucleic acid). The
Published: 2009-01-02 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-31214] 288. Guidance for Industry and Food and Drug Administration Staff; Class II
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA.'' This guidance document describes a means by which an enterovirus nucleic acid assay may comply with the requirement of special
Published: 2009-01-02 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-31187] 289. Blood Products Advisory Committee; Notice of Meeting; Amendment
The Food and Drug Administration (FDA) is announcing an amendment to the notice of the Blood Products Advisory Committee. This meeting was announced in the Federal Register of December 9, 2008 (73 FR 74725). The amendment is being made to reflect a change in the Agenda portion of the document.
Published: 2009-01-02 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-31217] 290. Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
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 advice and recommendations to the agency on FDA's regulatory
Published: 2009-01-02 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
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