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Drug user
Results: 1369

#	Item
531	SMG[removed]FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION FDA OFFICIAL COUNCILS AND COMMITTEES SCOPE OF QUALITY SYSTEM IMPLEMENTATION IN FDA Effective Date: [removed]. Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Office of Regulatory Affairs Process analytical technology Center for Biologics Evaluation and Research ISO/IEC 17025 Validation Quality by Design Food and Drug Administration Pharmaceutical sciences Medicine
532	Thomas X White Associate Vice President Manufacturing and Quality Control Add to Reading List Source URL: www.fda.gov Language: English - Date: 1999-09-20 08:30:54 Food and Drug Administration Health Clinical research Pharmaceuticals policy Prescription Drug User Fee Act New Drug Application Pharmaceutical Research and Manufacturers of America Good manufacturing practice Clinical trial Pharmaceutical sciences Pharmaceutical industry Pharmacology
533	201 Tabor Road Morris Plalns, NJ[removed]Phone Add to Reading List Source URL: www.fda.gov Language: English - Date: 1998-07-29 14:41:39 Health Food law Food and Drug Administration Modernization Act Parke-Davis Prescription Drug User Fee Act Pharmaceuticals policy Food and Drug Administration Pharmaceutical sciences
534	Comments on Guidance for Industry and FDA Staff: Application User Fees for Combination Products Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-01-05 16:26:05 Pharmaceutical sciences Prescription Drug User Fee Act Premarket approval Center for Devices and Radiological Health Medtronic Center for Drug Evaluation and Research Abbreviated New Drug Application FDA Special Protocol Assessment New Drug Application Food and Drug Administration Medicine Health
535	USER FEE OBLIGATIONS User fees are expended only for costs necessary to support the process for the review of medical device applications, as defined in MDUFA. Allowable and excludable costs for the process for the revie Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Food and Drug Administration Pharmacology Therapeutics United States Public Health Service Medical device Fee Medicine Health Pharmaceutical sciences
536	USER FEE COLLECTIONS MDUFA specifies that user fees shall be collected for medical device applications and annual fees shall be collected for establishment registration and periodic reporting through FY[removed]The statute Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Fee Medicinal chemistry Pharmaceutical sciences Clinical research FY
537	Wyeth Pharmaceuticals Wyeth Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-11-05 15:30:48 Prescription Drug User Fee Act Health Medicine Priority review voucher Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
538	1 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION PUBLIC MEETING: PRESCRIPTION DRUG USER FEE ACT Add to Reading List Source URL: www.fda.gov Language: English - Date: 2001-12-19 09:37:50 Health Prescription Drug User Fee Act Food and Drug Administration Modernization Act Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
539	Ellen R Westrick Senior Director Office of Medical/Legal US. Human Health Merck & Co., Inc. Add to Reading List Source URL: www.fda.gov Language: English - Date: 1998-07-29 14:42:12 Pharmaceutical sciences Pharmaceuticals policy Medicine Food and Drug Administration Modernization Act Food law Merck & Co. Off-label use Clinical research Prescription Drug User Fee Act Food and Drug Administration Health Pharmacology
540	[removed]Federal Register / Vol. 63, No[removed]Thursday, July 30, [removed]Notices The burden estimates are based on past experience and on discussions with registrants during routine Add to Reading List Source URL: www.fda.gov Language: English - Date: 1998-07-30 09:27:51 Health Food law Pharmacology United States Public Health Service Docket Prescription Drug User Fee Act Pharmaceuticals policy Food and Drug Administration Pharmaceutical sciences

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