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Center for Drug Evaluation and Research
Results: 4314

#	Item
191	Archived Geographic Monographs Add to Reading List Source URL: www.fda.gov Language: English Health Center for Drug Evaluation and Research ZIP code Office of Regulatory Affairs Food and Drug Administration Pharmaceutical sciences Clinical research
192	FDA Regulatory Process Michael J. Hoffmann, M.S. Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English Health Pharmacology Pharmaceutical industry Food and Drug Administration Investigational Device Exemption Center for Devices and Radiological Health Medical device Risk Clinical trial Medicine Clinical research Research
193	This document is scheduled to be published in the Federal Register on[removed]and available online at http://federalregister.gov/a[removed], and on FDsys.gov[removed]P DEPARTMENT OF HEALTH AND HUMAN SERVICES Add to Reading List Source URL: s3.amazonaws.com Language: English - Date: 2014-12-03 08:54:23 Pharmaceutical sciences Food and Drug Administration Pregnancy Prescription medication Package insert Center for Drug Evaluation and Research Adverse effect Structured Product Labeling Emergency contraception Medicine Pharmacology Health
194	FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Anti-Infective Drug Advisory Committee (AIDAC) Meeting The Marriott Inn and Conference Center, University of Maryland University College ( Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical industry Clinical pharmacology Center for Drug Evaluation and Research Drug discovery Drug development Pharmaceutical sciences Pharmacology Medicinal chemistry
195	FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research Anti-Infective Drugs Advisory Committee Roster ======================================================================= Chairperson CAPT Monica E. Paris Add to Reading List Source URL: www.fda.gov Language: English Public health Health Itzhak Brook Wafaa El-Sadr Centers for Disease Control and Prevention United States Public Health Service Medicine
196	REGULATION OF NONPRESCRIPTION DRUG PRODUCTS CDR Yoon Kong, Pharm.D. USPHS Division of Nonprescription Drug Products Center for Drug Evaluation and Research Add to Reading List Source URL: www.fda.gov Language: English Health Pharmacology Drug safety Drugs Over-the-counter drug New Drug Application Prescription medication Center for Drug Evaluation and Research Dietary supplement Medicine Pharmaceuticals policy Food and Drug Administration
197	FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research Anti-Infective Drugs Advisory Committee Roster ======================================================================= Chairperson CAPT Monica E. Paris Add to Reading List Source URL: www.fda.gov Language: English Public health Health Itzhak Brook Wafaa El-Sadr Centers for Disease Control and Prevention United States Public Health Service Medicine
198	FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Anti-Infective Drug Advisory Committee (AIDAC) Meeting The Marriott Inn and Conference Center, University of Maryland University College ( Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical pharmacology Pharmaceutical industry Therapeutics Center for Drug Evaluation and Research Drug discovery Pharmaceutical sciences Pharmacology Medicinal chemistry
199	Providing Regulatory Submissions In Electronic Format — Standardized Study Data Guidance for Industry Add to Reading List Source URL: www.fda.gov Language: English Clinical research Health Pharmaceutical industry Drug safety Pharmacology Clinical Data Interchange Standards Consortium Investigational New Drug SDTM Center for Biologics Evaluation and Research Food and Drug Administration Medicine Research
200	FDA and BRAT Frameworks for Structured Approaches to Benefit-risk Assessment Bennett Levitan, MD-PhD Department of Epidemiology, Janssen Research and Development American Statistical Association and Bayer HealthCare Work Add to Reading List Source URL: www.amstat.org Language: English - Date: 2013-11-16 12:23:38 Ethics Actuarial science Risk management Pharmaceuticals policy Security Prescription Drug User Fee Act Risk assessment Center for Drug Evaluation and Research Food and Drug Administration Risk Management

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