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Center for Drug Evaluation and Research
Results: 4314

#	Item
911	One Approach to Filling Measurement Gaps for PRO Endpoints Stephen Joel Coons, PhD Executive Director Patient-Reported Outcome (PRO) Consortium Critical Path Institute Add to Reading List Source URL: www.fda.gov Language: English Research Critical Path Institute Center for Drug Evaluation and Research Food and Drug Administration Patient-reported outcome Pharmaceutical industry Consortium Pharmaceutical sciences Pharmacology Clinical research
912	Staff Manual Guide[removed] Add to Reading List Source URL: www.fda.gov Language: English Center for Devices and Radiological Health Center for Biologics Evaluation and Research Medical device Premarket approval Center for Drug Evaluation and Research Federal Food Drug and Cosmetic Act Biologic Food and Drug Administration Medicine Health
913	Certificate of a Pharmaceutical Product (CPP) Application Process Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Food law Pharmaceuticals policy Pharmacology Adulteration Federal Food Drug and Cosmetic Act Title 21 of the United States Code Center for Drug Evaluation and Research Food and Drug Administration Medicine Health
914	SMG 4101 FDA STAFF MANUAL GUIDES, VOLUME IV - AGENCY PROGRAM DIRECTIVES COMBINATION PRODUCTS INTERCENTER CONSULTATIVE/COLLABORATIVE REVIEW PROCESS Effective Date: June 18, 2004 Add to Reading List Source URL: www.fda.gov Language: English Clinical research Biologic Center for Devices and Radiological Health Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Investigational New Drug Food and Drug Administration Medicine Health
915	Staff Manual Guide[removed] Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Health Drug safety Center for Drug Evaluation and Research United States Department of Health and Human Services Center for Biologics Evaluation and Research Investigational New Drug Biologic New Drug Application Food and Drug Administration Pharmacology Medicine
916	FDA’s Medical Countermeasures initiative (MCMi) and You Dr. Luciana Borio Add to Reading List Source URL: www.fda.gov Language: English Vaccination Clinical pharmacology Pharmacology United States Public Health Service Public Readiness and Emergency Preparedness Act Center for Biologics Evaluation and Research United States Department of Homeland Security Flu pandemic Chemical biological radiological and nuclear Medicine Health Food and Drug Administration
917	Drug Shortages – Causes, Progress, and Strategies EMS Drug Shortages Summit March 5, 2014 Erin R. Fox, PharmD, FASHP Director, Drug Information Service Add to Reading List Source URL: nasemso.org Language: English - Date: 2014-03-10 02:25:17 Clinical research American Society of Health-System Pharmacists Center for Drug Evaluation and Research Economic shortage Pharmaceutical sciences Food and Drug Administration Pharmacology
918	Regulatory Support for Blood Banking Submissions and Compliance Unique credentials in Blood Banking and Software Add to Reading List Source URL: www.softwarecpr.com Language: English - Date: 2005-10-13 10:20:52 Health Pharmaceutical industry Pharmacology Clinical research Validity Validation Center for Biologics Evaluation and Research Title 21 CFR Part 11 Medical device Medicine Food and Drug Administration Pharmaceutical sciences
919	ANTIVIRAL DRUGS ADVISORY COMMITTEE MEETING ROSTER Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Advisors and Consultants Staff Conference Room April 24, 2007 ANTIVIRAL DRUGS ADVISORY C Add to Reading List Source URL: www.fda.gov Language: English - Date: 2007-04-20 08:29:11
920	MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-06-28 09:23:57 Oxazolidinones Zolmitriptan Pharmaceutical sciences Adverse Event Reporting System Chemistry Clinical research Food and Drug Administration Triptans AstraZeneca Carbamates

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