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Drug user
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361	[removed]Federal Register / Vol. 73, No[removed]Monday, November 24, [removed]Notices Section 903(b)(2)(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences New Drug Application Debarment Center for Biologics Evaluation and Research Federal Food Drug and Cosmetic Act Biologic License Application Investigational New Drug Prescription Drug User Fee Act Criticism of the Food and Drug Administration Food and Drug Administration Medicine Health
362	FDASIA Small Business Report Add to Reading List Source URL: www.fda.gov. Language: English Health Pharmaceutical sciences Prescription Drug User Fee Act Priority review voucher New Drug Application Federal Food Drug and Cosmetic Act Pharmaceutical industry Center for Devices and Radiological Health Generic drug Food and Drug Administration Medicine Pharmaceuticals policy
363	Public Stakeholder Meeting on Biosimilars User Fee Program, June 24, 2011 Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical sciences Biosimilar Biotechnology Drugs Biologic Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Food and Drug Administration Clinical research Medicine
364	THE SECRETARY OF HEALTH AND HUMAN SERVICES WASHINGTON. D.C[removed]JUL[removed]The Honorable Edward M. Kennedy Chairman Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceuticals policy Pharmaceutical industry Clinical pharmacology Food and Drug Administration United States Public Health Service Generic drug User fee Animal drugs Drug Enforcement Administration Pharmaceutical sciences Pharmacology Clinical research
365	July 25, 2014 The Honorable Fred Upton, Chairman U.S. House of Representatives Committee on Energy & Commerce 2125 Rayburn House Office Building Add to Reading List Source URL: www.rarediseases.org Language: English - Date: 2014-07-28 12:01:38 Food and Drug Administration Pharmaceuticals policy Therapeutics United States Public Health Service Pharmaceutical industry Off-label use Methadone Prescription Drug User Fee Act Orphan drug Pharmacology Pharmaceutical sciences Clinical research
366	Benefit-risk balance assessment during life cycle of medicinal products Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceuticals policy Pharmacology Safety Clinical pharmacology United States Public Health Service Prescription Drug User Fee Act Risk assessment Food and Drug Administration Pharmaceutical sciences Risk
367	Generic Drug User Fee Amendments of 2012 Regulatory Science Initiatives: Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmaceutics Food and Drug Administration Bioequivalence Pharmacokinetics Generic drug Abbreviated New Drug Application NIPTE Center for Drug Evaluation and Research Pharmaceutical sciences Pharmacology Pharmaceuticals policy
368	OCP Update May 4, 2012 PhRMA IQC Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical industry Therapeutics United States Public Health Service Center for Drug Evaluation and Research Drug development Prescription Drug User Fee Act California Institute for Quantitative Biosciences Biosimilar Food and Drug Administration Pharmaceutical sciences Clinical research
369	PDUFA IV IT PLAN ABBREVIATED UPDATE MAY 2010 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Medicine Prescription Drug User Fee Act Electronic Common Technical Document Regulated Product Submissions Food and Drug Administration Pharmaceuticals policy Health
370	FDA Briefing Document Addendum for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Meeting Date: 15 January 2014 Add to Reading List Source URL: www.fda.gov Language: English Chemistry Carbamates Pyridines United States Public Health Service New Drug Application Prescription Drug User Fee Act Vorapaxar Food and Drug Administration Pharmaceutical sciences Pharmacology

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