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User fee
Results: 1551

#	Item
451	Guidance for Industry Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Pharmaceutical sciences Pharmacology Clinical research Food law Prescription Drug User Fee Act Bioequivalence Center for Biologics Evaluation and Research Clinical trial Food and Drug Administration Health Medicine
452	FY 2013 PERFORMANCE REPORT TO THE PRESIDENT AND CONGRESS for the Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Biosimilar Biotechnology Drugs Prescription Drug User Fee Act Biologic Abbreviated New Drug Application Pharmaceutical sciences Clinical research Pharmacology
453	FY 2003 PERFORMANCE REPORT Add to Reading List Source URL: www.fda.gov Language: English Prescription Drug User Fee Act Health Pharmacology Food law FDA Special Protocol Assessment Abbreviated New Drug Application Approved drug Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
454	Microsoft Word - Report to Congress - PDUFA Perf Report 041.doc Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act FDA Special Protocol Assessment New Drug Application Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
455	Microsoft PowerPoint - Plenary Session 1 - Cooper DIA_esub_Data_Standards_11_2011_Cooper.ppt [Compatibility Mode] Add to Reading List Source URL: www.fda.gov Language: English Medicine Clinical Data Interchange Standards Consortium Center for Drug Evaluation and Research Prescription Drug User Fee Act SDTM Food and Drug Administration Clinical research Research
456	FY 2003 PERFORMANCE REPORT Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act FDA Special Protocol Assessment New Drug Application Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
457	The Future of Drug Safety — Promoting and Protecting the Health of the Public FDA’s Response to the Institute of Medicine’s 2006 Report Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences Pharmacology Pharmaceuticals policy Drug safety United States Public Health Service Prescription Drug User Fee Act Patient safety Pharmacovigilance MedWatch Medicine Food and Drug Administration Health
458	FY 2003 PERFORMANCE REPORT Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Food law FDA Special Protocol Assessment Drug safety New Drug Application FY Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
459	Appendix 1: Medical Device User Fee Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Prescription Drug User Fee Act Center for Devices and Radiological Health Medical device Fee Biologic License Application Food and Drug Administration Medicine Health
460	BioProcess International Conference Boston, Massachusetts October 2, 2007 Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Pharmaceutical industry Pharmacology United States Public Health Service Prescription Drug User Fee Act Regulatory requirement Investigational New Drug Quality management system Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences

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