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#	Item
41	SOPP[removed]: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA) Version #2 Effective Date: December, 1, 2013 I. Purpose Add to Reading List Source URL: www.fda.gov Language: English Health Center for Biologics Evaluation and Research Prescription Drug User Fee Act European Medicines Agency Food and Drug Administration Pharmaceutical sciences Medicine
42	SOPP 8420: FDAAA Section 921: Posting of Potential Signals of Serious Risk Version #1 Effective Date: November 1, 2011 I. Purpose Add to Reading List Source URL: www.fda.gov Language: English Health Adverse Event Reporting System Center for Biologics Evaluation and Research MedWatch Pharmacovigilance Center for Drug Evaluation and Research Safety monitoring Purple glove syndrome Food and Drug Administration Pharmaceutical sciences Medicine
43	SOPP[removed]: Appendix A Agencies’ Liaisons: Deputy Director, FDA Europe Office Liaison to EMA (DDEO), FDA Office of International Programs (OIP): Janice Soreth, M.D. ([removed]_) Add to Reading List Source URL: www.fda.gov
44	CBER SOPP[removed]: Interoffice Consultative Review Add to Reading List Source URL: www.fda.gov
45	SOPP 8407 Compliance Status Checks Appendix 1 Establishment Evaluation Request Add to Reading List Source URL: www.fda.gov Language: English FEI BLA
46	SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments Add to Reading List Source URL: www.fda.gov Language: English Research Clinical research Pharmaceutical industry Epidemiology Drug safety Pharmacovigilance Clinical trial Food and Drug Administration Pharmaceutical sciences Health Pharmacology
47	SOPP 8203: Evaluation of Cost Recovery Requests for Investigational New Drugs and Investigational Device Exemptions Version 1 Effective Date: January 15, 2013 I. Purpose Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Medicine Pharmaceutical industry Clinical research Pharmaceuticals policy Expanded access Investigational New Drug Center for Biologics Evaluation and Research Regulatory requirement Food and Drug Administration Pharmaceutical sciences Health
48	SOPP 8704: Managing MDUFA User Fee Payments and Billing Activities Version #3 Effective Date: October 15, 2012 I. Purpose Add to Reading List Source URL: www.fda.gov Language: English Prescription Drug User Fee Act Premarket approval Medical device Federal Food Drug and Cosmetic Act New Drug Application Center for Devices and Radiological Health Center for Biologics Evaluation and Research Fee Food and Drug Administration Medicine Health
49	Department of Commerce ∙ National Oceanic & Atmospheric Administration ∙ National Marine Fisheries Service NATIONAL MARINE FISHERIES SERVICE INSTRUCTION[removed]NOVEMBER 3, 2010 Fisheries Management Fishery Manage Add to Reading List Source URL: www.nmfs.noaa.gov Language: English - Date: 2014-08-13 09:39:54 Magnuson–Stevens Fishery Conservation and Management Act Fisheries science Sopp National Oceanic and Atmospheric Administration Fisheries management United States Department of Commerce Fish Environment Fishing National Marine Fisheries Service
50	Human Research Subject Protection and Institutional Review Boards (IRB) Standard Operating Policies and Procedures (SOPP) Office of Regulatory Research Compliance Add to Reading List Source URL: www.orrchoward.com Language: English - Date: 2014-07-08 13:36:46 Science Pharmaceutical sciences Design of experiments Medical ethics Pharmaceutical industry Institutional review board Clinical trial Informed consent Food and Drug Administration Pharmacology Research Clinical research