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Prescription Drug User Fee Act
Results: 1007

#	Item
61	User Fees According to Goldilocks: Getting Your User Fees Just Right October 27, 2014 Center for Drug Evaluation and Research (CDER) – Office of Management Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical industry Health policy Prescription Drug User Fee Act Center for Drug Evaluation and Research Generic drug Fee Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
62	New 2010 Pipeline Database Add to Reading List Source URL: www.catamaranrx.com Language: English - Date: 2014-08-08 11:48:04 Food and Drug Administration Anorectics Pharmacology Pharmaceuticals policy Therapeutics Prescription Drug User Fee Act Exenatide Anti-obesity medication Dipeptidyl peptidase-4 inhibitor Health Pharmaceutical sciences Medicine
63	Public Meeting on Female Sexual Dysfunction Patient-Focused Drug Development October 27, 2014 1 Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Clinical research Prescription Drug User Fee Act Food and Drug Administration Pharmaceutical sciences Pharmaceuticals policy
64	CDER New Drug Review Update Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Medicine Priority review voucher Center for Drug Evaluation and Research Abbreviated New Drug Application Food and Drug Administration Pharmaceuticals policy Prescription Drug User Fee Act
65	Recommendations from the Generic Industry Working Group for Regulations of Abuse-Deterrent Opioid Formulations Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmacology Medical informatics Pharmaceutical industry Pharmaceuticals policy Prescription Drug User Fee Act Abbreviated New Drug Application Package insert Pharmaceutical sciences Medicine Health
66	Medivation Contacts: Patrick Machado Chief Business & Financial Officer[removed]Astellas Contacts: Add to Reading List Source URL: www.astellas.com Language: English - Date: 2012-08-05 19:26:01 Prostate cancer MDV3100 Prescription Drug User Fee Act Docetaxel Food and Drug Administration Astellas Pharma Chemistry Medicine Organic chemistry
67	Rare Pediatric Disease Priority Review Vouchers, Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: November 17, 2014 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Orphan drug Priority review voucher FDA Fast Track Development Program New Drug Application Orphan Drug Act Center for Biologics Evaluation and Research Prescription Drug User Fee Act Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
68	Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmacy Food and Drug Administration Pharmaceuticals policy Medical informatics Prescription Drug User Fee Act Structured Product Labeling Pharmacovigilance Electronic prescribing Medicine Health Pharmaceutical sciences
69	KEI Research Note 2014:3 (draft 2) Size of Clinical Trials, data from the FDA 2010 NME and BLA approvals, preliminary results Elizabeth Rajasingh November 27, 2014 Add to Reading List Source URL: keionline.org Language: English - Date: 2014-11-17 12:49:45 Health Drug discovery Pharmaceutical industry Food and Drug Administration Pharmaceuticals policy Clinical trial Drug development Orphan drug Prescription Drug User Fee Act Pharmaceutical sciences Pharmacology Clinical research
70	RepliGen Sandford D. Smith President and Chief Executive 01ficer Repligen Corporation Add to Reading List Source URL: www.clintonlibrary.gov Language: English - Date: 2014-06-13 22:34:43 Pharmacology Food and Drug Administration Drug discovery Pharmaceutical industry Prescription Drug User Fee Act Orphan drug Orphan Drug Act Pharmaceutical marketing Biotechnology Pharmaceutical sciences Pharmaceuticals policy Health

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