and Cosmetic Act

Results: 5012



#Item
651Technology / Medical device / Center for Devices and Radiological Health / 9 / New Drug Application / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Prescription Drug User Fee Act / Food and Drug Administration / Medicine / Health

UNITED STATES OF AMERICAPRIVATE + + + + +

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Source URL: www.fda.gov

Language: English
652Safety / Nutrition / Center for Food Safety and Applied Nutrition / Food law / Federal Food /  Drug /  and Cosmetic Act / Food safety / Food and Drug Administration / Health / Medicine

Staff Manual Guide[removed]

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Source URL: www.fda.gov

Language: English
653Technology / Center for Devices and Radiological Health / Premarket approval / Medical device / Federal Food /  Drug /  and Cosmetic Act / Microchip implant / Unique Device Identification / Medicine / Food and Drug Administration / Health

[Executive Summary 1 page – to be completed once content is agreed upon]

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Source URL: www.fda.gov

Language: English
654Health / Food law / Pharmacology / Therapeutics / United States Public Health Service / Complaint / Federal Food /  Drug /  and Cosmetic Act / Center for Tobacco Products / Food and Drug Administration / Medicine / Pharmaceutical sciences

Administrative Complaint For Civil Money Penalties FDA Docket No. FDA-2014-H-0346 CRD Docket No. C[removed]

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Source URL: www.fda.gov

Language: English
655Pharmaceutical sciences / Center for Veterinary Medicine / CVM / Animal drugs / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Health

Staff Manual Guide[removed]

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Source URL: www.fda.gov

Language: English
656Technology / Food law / Pharmaceuticals policy / Pharmacology / United States Public Health Service / Medical device / Title 21 of the Code of Federal Regulations / Federal Food /  Drug /  and Cosmetic Act / Premarket approval / Medicine / Food and Drug Administration / Health

Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories

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Source URL: www.fda.gov

Language: English
657Research / Structured Product Labeling / Center for Biologics Evaluation and Research / Adverse Event Reporting System / Validation / Electronic Common Technical Document / Federal Food /  Drug /  and Cosmetic Act / Abbreviated New Drug Application / Title 21 CFR Part 11 / Food and Drug Administration / Medicine / Health

Guidance for Industry Electronic Submission of Lot Distribution Reports DRAFT GUIDANCE This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance b

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Source URL: www.fda.gov

Language: English
658Health / Pharmacology / Pharmaceuticals policy / Clinical pharmacology / United States Public Health Service / Federal Food /  Drug /  and Cosmetic Act / Center for Drug Evaluation and Research / Food and Drug Administration / Medicine / Pharmaceutical sciences

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993

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Source URL: www.fda.gov

Language: English
659Pharmaceutical sciences / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Center for Biologics Evaluation and Research / Title 21 of the Code of Federal Regulations / Paperwork Reduction Act / Food and Drug Administration / Medicine / Health

[removed]Federal Register / Vol. 79, No[removed]Tuesday, October 14, [removed]Notices ANNUAL BURDEN ESTIMATES Average burden hours

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Source URL: www.gpo.gov

Language: English - Date: 2014-10-15 16:38:04
660Health / Investigational Device Exemption / Premarket approval / Medical device / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration Modernization Act / Center for Devices and Radiological Health / Design controls / Validation / Food and Drug Administration / Medicine / Technology

The New 510(k) Paradigm Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications

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Source URL: www.fda.gov

Language: English
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