User fee

Results: 1551



#Item
671Pharmaceuticals policy / Drug discovery / Food and Drug Administration / Pharmaceutical industry / Prescription Drug User Fee Act / Clinical trial / Orphan drug / Gemtuzumab ozogamicin / Drug development / Pharmacology / Pharmaceutical sciences / Medicine

Published OnlineFirst June 20, 2012; DOI: [removed].CCR[removed]Rare Cancer Trial Design: Lessons from FDA Approvals Himabindu Gaddipati, Ke Liu, Anne Pariser, et al. Clin Cancer Res Published OnlineFirst June 2

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Source URL: clincancerres.aacrjournals.org

Language: English
672Health / Pharmaceutical sciences / Pharmacology / Drug safety / Pharmaceutical industry / Center for Drug Evaluation and Research / Prescription Drug User Fee Act / Generic drug / Abbreviated New Drug Application / Food and Drug Administration / Pharmaceuticals policy / Medicine

HUMAN DRUGS The FY 2010 program level budget request for the FDA Human Drugs Program is $908,013,000. The following table shows a three-year funding history for the Human Drugs Program. FDA Program Resources Table FY 20

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Source URL: www.fda.gov

Language: English
673Biotechnology / Center for Biologics Evaluation and Research / Biologic / Prescription Drug User Fee Act / Influenza vaccine / Vaccine / Office of Regulatory Affairs / Influenza / Adverse effect / Food and Drug Administration / Medicine / Health

BIOLOGICS The FY 2010 program level budget submission for the FDA Biologics Program is $305,731,000. The following table shows a three-year funding history for the Biologics Program. FDA Program Resources Table FY 2008

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Source URL: www.fda.gov

Language: English
674Food and Drug Administration / Pharmacology / Therapeutics / United States Public Health Service / Prescription Drug User Fee Act / Pharmaceutical sciences / Clinical research / Clinical pharmacology

EXECUTIVE SUMMARY The Animal Drug User Fee Act (ADUFA) of 2003, as amended in 2008, requires the Food and Drug Administration (FDA) to report annually on the financial aspects of its implementation of ADUFA. This report

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Source URL: www.fda.gov

Language: English
675Pricing / Food and Drug Administration / FY / Pharmacology / Prescription Drug User Fee Act / Pharmaceutical sciences / Clinical research / Fee

USER FEE COLLECTIONS ADUFA specifies that user fees shall be collected for certain animal drug applications and supplements upon their submission, and annual fees shall be collected for certain products, establishments,

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Source URL: www.fda.gov

Language: English
676Pharmacology / Health / Pharmaceuticals policy / Clinical pharmacology / United States Public Health Service / Abbreviated New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Prescription Drug User Fee Act / Food and Drug Administration / Pharmaceutical sciences / Medicine

APPENDIX D ALLOWABLE AND EXCLUDED COSTS FOR THE PROCESS FOR THE REVIEW OF ANIMAL DRUG APPLICATIONS The FD&C Act, as amended by ADUFA II, Public Law No[removed], defines the process for the review of animal drug applicati

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Source URL: www.fda.gov

Language: English
677Health / Medicine / Pharmaceuticals policy / Food law / Therapeutics / Pharmaceutical industry / Federal Food /  Drug /  and Cosmetic Act / Prescription Drug User Fee Act / Pharmaceutical sciences / Pharmacology / Food and Drug Administration

BACKGROUND The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by ADUFA, authorizes FDA to collect fees from the animal pharmaceutical industry to augment appropriations spent on FDA’s animal drug review pr

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Source URL: www.fda.gov

Language: English
678Food and Drug Administration / Pharmacology / Pharmaceutical industry / United States Public Health Service / Prescription Drug User Fee Act / Generic drug / Court reporter / Pharmaceuticals policy / Pharmaceutical sciences / Law

Transcript: Public Meeting on Proposed Recommendations for a Human Generic Drug User Fee

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Source URL: www.fda.gov

Language: English
679Pharmacology / Food and Drug Administration / Pharmaceutical industry / Therapeutics / Generic drug / Abbreviated New Drug Application / Prescription Drug User Fee Act / Criticism of the Food and Drug Administration / Pharmaceutical sciences / Pharmaceuticals policy / Health

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may

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Source URL: www.fda.gov

Language: English
680Tax / Business / Value added tax / Property tax / Excise / User fee / Sales tax / Fee / Sales taxes in the United States / Public finance / Public economics / Political economy

C I T Y O F F O R T LAU D ER D ALE revenue manual REVENUE MANUAL

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Source URL: www.fortlauderdale.gov

Language: English - Date: 2013-05-01 15:07:41
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