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Center for Drug Evaluation and Research
Results: 4314

#	Item
981	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 It was current when produced, but is no longer maintained and may Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Clinical research NicOx SBF 120 Naproxcinod COX-inhibiting nitric oxide donator Center for Drug Evaluation and Research New Drug Application Food and Drug Administration Non-steroidal anti-inflammatory drugs Pharmaceutical sciences
982	APPENDIX E DEVELOPMENT OF COSTS FOR THE PROCESS FOR THE REVIEW OF ABBREVIATED APPLICATIONS FOR GENERIC NEW ANIMAL DRUGS GENERAL METHODOLOGY The costs associated with the process for the review of abbreviated application Add to Reading List Source URL: www.fda.gov Language: English Clinical research Abbreviated New Drug Application Office of Regulatory Affairs Cost Center for Veterinary Medicine Clinical trial Center for Food Safety and Applied Nutrition Center for Drug Evaluation and Research Food and Drug Administration Pharmaceutical sciences Health
983	Testimony of Kathleen Hoke Dachille FDA Center for Drug Evaluation and Research Docket No. FDA-2012-N-1148 December 17, 2012 My name is Kathleen Hoke Dachille and I am speaking today on behalf of the Tobacco Control Lega Add to Reading List Source URL: publichealthlawcenter.org Language: English - Date: 2013-01-24 11:22:45 Family Smoking Prevention and Tobacco Control Act Electronic cigarette Dissolvable tobacco Nicotine Cigarette Snus Regulation of tobacco by the U.S. Food and Drug Administration Food and Drug Administration Smoking Tobacco Ethics Addiction
984	DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality Division of Manufacturing and Product Quality Add to Reading List Source URL: www.fda.gov Language: English Biotechnology Biogen Idec IDEC Peripheral membrane proteins Recombinant DNA Coagulation Factor IX Biologic Coagulation system Haemophilia Biology
985	Barcoding -- A Regulatory Initiative – July 26, 2002 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2002-11-27 11:11:02 Clinical research Steven K. Galson Lester Crawford Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Food and Drug Administration Health Medicine
986	HEALTH ECONOMICS Health Econ. 16: 219–[removed]Published online in Wiley InterScience (www.interscience.wiley.com). DOI: [removed]hec.1222 GUEST EDITORIAL THE INSTITUTE OF MEDICINE REPORT ON THE FDA: Add to Reading List Source URL: www.manhattan-institute.org Language: English - Date: 2008-09-23 13:04:44 Health Pharmaceuticals policy Pharmacy Prescription Drug User Fee Act Rofecoxib Pharmaceutical industry Center for Drug Evaluation and Research Pharmacovigilance Criticism of the Food and Drug Administration Pharmaceutical sciences Food and Drug Administration Pharmacology
987	June 5, 2014 Janet Woodcock, M.D. Director Center for Drug Evaluation and Research Food and Drug Administration Department of Health and Human Services Add to Reading List Source URL: www.citizen.org Language: English - Date: 2014-06-18 15:48:36 Endocrine system Peptide hormones Pancreas disorders Diabetes Medical emergencies Liraglutide Incretin Anti-diabetic medication Exenatide Anti-diabetic drugs Medicine Gastroenterology
988	Revisions to Guidance to Industry 2125fnl.PDF Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Prescription Drug User Fee Act Center for Biologics Evaluation and Research New Drug Application Investigational New Drug FDA Special Protocol Assessment Center for Drug Evaluation and Research Biologic Generic drug Food and Drug Administration Medicine Health
989	Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting May 22, 2013 Location: The FDA White Oak Campus, Building Add to Reading List Source URL: www.fda.gov Language: English Nonbenzodiazepines Sanofi Amines Imidazopyridines Zolpidem Methadone Hydromorphone Eszopiclone Chemistry Organic chemistry Ketones
990	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 Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Clinical research NicOx SBF 120 Naproxcinod COX-inhibiting nitric oxide donator Center for Drug Evaluation and Research Non-steroidal anti-inflammatory drugs Food and Drug Administration Pharmaceutical sciences

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