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Adverse Event Reporting System
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171	Improving the basis for FDA CBER identification of adverse effects of blood products and vaccines Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Safety Drug safety Centers for Disease Control and Prevention Public safety Center for Biologics Evaluation and Research Adverse Event Reporting System Biologic Postmarketing surveillance Medicine Health Pharmacology
172	Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Date: Add to Reading List Source URL: www.fda.gov Language: English Drug safety Adverse Event Reporting System Food and Drug Administration Pharmacovigilance ISTA Pharmaceuticals Pharmaceutical sciences Pharmacology Clinical research
173	FDA Regional Technical Specifications for ICH E2B (R3) Implementation Postmarket Submission of Individual Case Safety Reports (ICSRs) for Vaccines Draft Technical Specifications Document This Document is incorporated by Add to Reading List Source URL: www.fda.gov Language: English Research Drug safety Medical informatics Clinical research Clinical Data Management Vaccine Adverse Event Reporting System Structured Product Labeling Electronic Common Technical Document Adverse Event Reporting System Medicine Food and Drug Administration Health
174	FDAAA Accomplishments – One Year After Enactment Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Prescription Drug User Fee Act Adverse Event Reporting System ClinicalTrials.gov Center for Biologics Evaluation and Research Federal Food Drug and Cosmetic Act Unique Device Identification Validation Direct-to-consumer advertising Food and Drug Administration Medicine Health
175	FDA POST-MARKET DRUG SURVEILLANCE: IN NEED OF AN OVERHAUL by Katie Zingg FOOD & DRUG LAW Add to Reading List Source URL: www.iflr.msu.edu Language: English - Date: 2011-03-29 12:13:02 Health Drug safety Clinical research Pharmaceutical industry Adverse Event Reporting System Pharmacovigilance Center for Drug Evaluation and Research Approved drug MedWatch Food and Drug Administration Pharmaceutical sciences Pharmacology
176	Microsoft Word[removed]2_12[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Clinical pharmacology Therapeutics United States Public Health Service Center for Drug Evaluation and Research Adverse Event Reporting System Generic drug Safety Food and Drug Administration Pharmaceutical sciences Pharmacology
177	U.S. Department of Health and Human Services MEDWATCH For VOLUNTARY reporting of adverse events, product problems and Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical industry Clinical research Health MedWatch Adverse event Serious adverse event Medical device Adverse Event Reporting System Medicine Pharmacology Pharmaceutical sciences
178	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: 2006-03-14 13:56:21 Irbesartan Adverse Event Reporting System Chemistry Organic chemistry Angiotensin II receptor antagonist
179	JOURNAL OF WOMEN’S HEALTH Volume 16, Number 6, 2007 © Mary Ann Liebert, Inc. DOI: [removed]jwh[removed]Special Report Add to Reading List Source URL: www.fda.gov Language: English Piperazines Cardiac electrophysiology QT interval Adverse Event Reporting System Torsades de pointes Breast implant Norfloxacin Clinical research Approved drug Medicine Health Food and Drug Administration
180	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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