Agency: Food and Drug Administration
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[FR Doc E7-25165] 1. Exceptions or Alternatives to Labeling Requirements for Products Held by the
The Food and Drug Administration (FDA) is issuing regulations
to permit FDA Center Directors to grant exceptions or alternatives to
certain regulatory labeling requirements applicable to human drugs, biological products, or
[[Page 73590]]
medical devices that are or will be included in the Strategic National
Stockpile (SNS). Under this rule, the
Published: 2007-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-25124] 2. Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
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: Cellular, Tissue and Gene Therapies Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the
Published: 2007-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-25310] 3. Draft Prescription Drug User Fee Act IV Information Technology Plan;
The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan.'' This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving
Published: 2007-12-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24974] 4. New Animal Drugs; Change of Sponsor's Name
The Food and Drug Administration (FDA) is amending the [[Page 72921]]
animal drug regulations to reflect a change of sponsor's name from
Altana, Inc., to Nycomed US, Inc.
Published: 2007-12-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24914] 5. Agency Emergency Processing Under the Office of Management and Budget Review;
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 12, 2007 (72 FR 70599). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995. The document was
Published: 2007-12-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24911] 6. DSM Nutritional Products, Inc.; Filing of Color Additive Petition;
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of December 4, 2007 (72 FR 68166). The document announced that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive
Published: 2007-12-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24927] 7. Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in clinical trial design for communityacquired pneumonia. This public workshop is intended to provide information for and to gain perspective from health care providers, academia,
Published: 2007-12-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24960] 8. Maximizing the Public Health Benefit of Adverse Event Collection Throughout a
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public workshop entitled ``Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle.'' The purpose of the public workshop is to
Published: 2007-12-26 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24812] 9. Pulmonary-Allergy 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: PulmonaryAllergy Drugs Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.
Published: 2007-12-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24813] 10. Health Claims and Qualified Health Claims; Dietary Lipids and Cancer, Soy
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on its intent to reevaluate the scientific evidence for two previously authorized health claims (dietary lipids (fat) and cancer; soy protein and risk of coronary heart disease) and two qualified health claims that were the subject of letters of enforcement
Published: 2007-12-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 07-6111] 11. Over-the-Counter Vaginal Contraceptive and Spermicide Drug Products
The Food and Drug Administration (FDA) is issuing a final rule establishing new warning statements and other labeling information for all overthecounter (OTC) vaginal contraceptive drug products (also known as spermicides, hereinafter referred to as vaginal contraceptives or vaginal contraceptives/spermicides) containing nonoxynol 9 (N9). These
Published: 2007-12-19 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24620] 12. Medical Devices; Availability of Safety and Effectiveness Summaries for
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Published: 2007-12-19 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24629] 13. Cellular, Tissue and Gene Therapies 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: Cellular, Tissue and Gene Therapies Advisory Committee.
[[Page 71923]]
General Function of the Committee: To provide advice and recommendations to the agency on
Published: 2007-12-19 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24627] 14. Psychopharmacologic 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: Psychopharmacologic Drugs Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.
Published: 2007-12-19 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24580] 15. Food and Drug Administration Modernization Act of 1997: Modifications to the
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 019'' (Recognition List
Published: 2007-12-19 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24431] 16. International Conference on Harmonisation; Draft Guidance on Q4B Evaluation
The Food and Drug Administration (FDA) is announcing the availability of a draft 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 draft guidance was prepared under the auspices of the International
Published: 2007-12-17 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24434] 17. International Conference on Harmonisation; Draft Guidance on Q4B Evaluation
The Food and Drug Administration (FDA) is announcing the availability of a draft 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 draft guidance was prepared under the auspices of the International
Published: 2007-12-17 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24385] 18. Guidance for Industry and Food and Drug Administration Review Staff:
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods,'' dated December 2007. The guidance document provides to blood establishments and FDA staff revised recommendations for the collection of Platelets by automated
Published: 2007-12-17 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24146] 19. New Animal Drugs for Use in Animal Feeds; Oxytetracycline
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pennfield Oil Co. that provides for a zero day preslaughter withdrawal time following use of oxytetracycline in turkey and swine feed.
Published: 2007-12-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24145] 20. New Animal Drugs For Use in Animal Feeds; Ractopamine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for an increased level of monensin in threeway combination Type C medicated feeds containing ractopamine, melengestrol, and monensin
Published: 2007-12-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24123] 21. 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: 2007-12-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-24144] 22. Quality System Regulation Educational Forum on Design Controls; Public
The Food and Drug Administration (FDA) is announcing an amendment to the notice of public workshop entitled ``Quality System Regulation Educational Forum on Design Controls.'' This workshop was announced in the Federal Register of October 11, 2007 (72 FR 57951). The amendment is made to reflect a change in the Location portion of the document.
Published: 2007-12-13 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc 07-6023] 23. Agency Emergency Processing Under the Office of Management and Budget Review;
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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the certification to accompany human drug, biological product,
Published: 2007-12-12 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-23962] 24. 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: 2007-12-11 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E7-23976] 25. 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 and to allow 60 days
Published: 2007-12-11 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
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