Food and Drug Administration Amendments Act

Results: 135



#Item
31EXECUTIVE SUMMARY The Prescription Drug User Fee Act (PDUFA) of 1992, as amended, requires the Food and Drug Administration (FDA or the agency) to report annually on the financial aspects of its implementation of the Act

EXECUTIVE SUMMARY The Prescription Drug User Fee Act (PDUFA) of 1992, as amended, requires the Food and Drug Administration (FDA or the agency) to report annually on the financial aspects of its implementation of the Act

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Source URL: www.fda.gov

Language: English
32Microsoft Word - PDUFA FY 2011 clean[removed]doc

Microsoft Word - PDUFA FY 2011 clean[removed]doc

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Source URL: www.fda.gov

Language: English
33Food and Drug Administration Advisory Committee Member Acknowledgment of Financial Interests

Food and Drug Administration Advisory Committee Member Acknowledgment of Financial Interests

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Source URL: www.fda.gov

Language: English
34PDMA DRAFT Q & A DOCUMENT

PDMA DRAFT Q & A DOCUMENT

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Source URL: www.fda.gov.

Language: English
35Guidance for Industry Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

Guidance for Industry Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

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Source URL: www.fda.gov

Language: English
36FDA Drug Review in PDUFA IV John K. Jenkins, MD Director, Office of New Drugs (CDER) 1

FDA Drug Review in PDUFA IV John K. Jenkins, MD Director, Office of New Drugs (CDER) 1

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Source URL: www.fda.gov

Language: English
37Microsoft Word - Retrospective Review Final.doc

Microsoft Word - Retrospective Review Final.doc

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Source URL: www.fda.gov.

Language: English
38Responsiveness Summary for the Amendments to the Model Toxics Control Act Cleanup Regulation Chapter[removed]WAC

Responsiveness Summary for the Amendments to the Model Toxics Control Act Cleanup Regulation Chapter[removed]WAC

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Source URL: www.ecy.wa.gov

Language: English - Date: 2008-05-12 13:23:20
39Clinical Trials Disclosure  Henry Durivage, Pharm.D. Associate Director, Clinical Trials and Regulatory Affairs Yale Center for Clinical Investigation

Clinical Trials Disclosure Henry Durivage, Pharm.D. Associate Director, Clinical Trials and Regulatory Affairs Yale Center for Clinical Investigation

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Source URL: ycci.yale.edu

Language: English - Date: 2014-11-11 08:53:57
40Drug Name Presentation Title

Drug Name Presentation Title

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Source URL: www.fda.gov

Language: English - Date: 2008-03-31 14:45:54