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Adverse Event Reporting System
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591	06.3 HHS PIA Summary for Posting (Form) / FDA CDER Adverse Event Reporting System [System] PIA SUMMARY AND APPROVAL COMBINED PIA Summary Is this a new PIA 2011? Yes If this is an existing PIA, please provide a reason for Add to Reading List Source URL: www.hhs.gov Language: English - Date: 2014-07-19 00:20:45 Pharmaceutical sciences Personally identifiable information New Drug Application Internet privacy Center for Drug Evaluation and Research Adverse Event Reporting System Privacy Investigational New Drug Structured Product Labeling Food and Drug Administration Medicine Health
592	Computerized Systems Used in Medical Device Clinical Investigations Presented by Jonathan Helfgott Consumer Safety Officer Division of Bioresearch Monitoring Office of Compliance Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Technology Pharmaceutical industry pharmacology Adverse Event Reporting System Medical device Clinical investigator Regulatory requirement Electronic patient-reported outcome Clinical research Medicine Research
593	A MEDWATCH CONTINUING EDUCATION ARTICLE Provided as a service by the Staff College, Center for Drug Evaluation and Research, Food and Drug Administration October[removed]THE CLINICAL IMPACT OF ADVERSE EVENT REPORTING Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Clinical research Pharmaceutical industry Drug safety Adverse Event Reporting System MedWatch Adverse effect Postmarketing surveillance Medicine Health Food and Drug Administration
594	U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition CFSAN Adverse Event Reporting System Voluntary and Mandatory Reports on 5-Hour Energy, Monster Energy Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Research Medicine Pharmacology Adverse event Serious adverse event MedWatch Canadian Anti-racism Education and Research Society Energy drink Clinical research Pharmaceutical industry Pharmaceutical sciences
595	Adverse Drug Experience (ADE) Reporting System Food and Drug Administration Center for Veterinary Medicine Division of Veterinary Product Safety: Dr. John Baker, Director Add to Reading List Source URL: www.fda.gov Language: English Medicine Adverse effect Food and Drug Administration Adverse event Pharmacovigilance Dvm Adverse drug reaction Abbreviated New Drug Application Pharmacology Pharmaceutical sciences Health
596	Special Communications Introducing MEDWatch A New Approach to Reporting Medication and Device Adverse Effects and Product Problems David A. Kessler, MD, for the Working Group Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Health Pharmaceutical industry Clinical research Patient safety MedWatch Adverse Event Reporting System Adverse effect Pharmacovigilance Medicine Food and Drug Administration Pharmacology
597	Understanding the Vaccine Adverse Event Reporting System (VAERS) Add to Reading List Source URL: www.fda.gov Language: English Vaccines Prevention Food and Drug Administration Public safety Vaccine Adverse Event Reporting System Vaccine injury Anthrax vaccines Medicine Safety Drug safety
598	Guidance for Industry: How to Complete the Vaccine Adverse Events Reporting System Form (VAERS-1) Add to Reading List Source URL: www.fda.gov Language: English Drug safety Food and Drug Administration Pharmacology Vaccines Vaccination Vaccine Adverse Event Reporting System Vaccine injury Adverse effect National Childhood Vaccine Injury Act Medicine Health Safety
599	PDF Document Add to Reading List Source URL: media.wiley.com Language: English - Date: 2008-10-16 05:02:06 Health Biosimilar Center for Biologics Evaluation and Research Biologic License Application Biologic Center for Drug Evaluation and Research Biopharmaceutical Adverse Event Reporting System Validation Food and Drug Administration Pharmaceutical sciences Medicine
600	Scientific Technologies Corporation Advancing Population Health Outcomes through Information Technology PRODUCT SUITE Advancing Health Outcomes Add to Reading List Source URL: www.stchome.com Language: English - Date: 2014-03-25 18:41:10 Centers for Disease Control and Prevention Drug safety Medical informatics Public health Healthcare Effectiveness Data and Information Set Immunization registry Vaccine Adverse Event Reporting System Clinical surveillance Immunization Health Medicine Health informatics

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