Adverse Event Reporting System

Results: 638



#Item
571Health / Adverse Event Reporting System / Center for Biologics Evaluation and Research / Electronic Common Technical Document / Center for Drug Evaluation and Research / Abbreviated New Drug Application / Title 21 CFR Part 11 / Structured Product Labeling / Food and Drug Administration / Medicine / Clinical research

Guidance for Industry Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers U.S. Department of Health and Human Services

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Source URL: www.fda.gov

Language: English
572Health / Adverse Event Reporting System / Center for Biologics Evaluation and Research / Electronic Common Technical Document / Center for Drug Evaluation and Research / Abbreviated New Drug Application / Title 21 CFR Part 11 / Structured Product Labeling / Food and Drug Administration / Medicine / Clinical research

Guidance for Industry Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers U.S. Department of Health and Human Services

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Source URL: www.fda.gov

Language: English
573Prevention / Drug safety / Centers for Disease Control and Prevention / Public safety / Virology / Vaccine Adverse Event Reporting System / Rotavirus vaccine / Vaccine Safety Datalink / Vaccine / Vaccines / Medicine / Vaccination

Ensuring the Safety of Vaccines in the United States

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Source URL: www.fda.gov

Language: English
574Health / Drug safety / Food and Drug Administration / Clinical research / Adverse Event Reporting System / Pharmaceuticals policy / Pharmacovigilance / Uppsala Monitoring Centre / Adverse event / Pharmacology / Pharmaceutical sciences / Medicine

Drug Safety 2005; 28 (11): [removed][removed]/$[removed]LEADING ARTICLE  2005 Adis Data Information BV. All rights reserved.

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Source URL: www.fda.gov

Language: English
575Research / Drug safety / Clinical research / Pharmaceutical industry / Food and Drug Administration / Pharmacovigilance / Adverse event / New Drug Application / Adverse Event Reporting System / Pharmaceutical sciences / Pharmacology / Medicine

Microsoft Word - 7950dft.doc

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Source URL: www.fda.gov

Language: English
576Biotechnology / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / Adverse Event Reporting System / Biologic / New Drug Application / Animal drugs / Title 21 of the Code of Federal Regulations / Code of Federal Regulations / Food and Drug Administration / Medicine / Health

Food and Drug Administration Regulations; Drug and Biological Product Consolidation; Addresses; Technical Amendment; Final Rule

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Source URL: www.fda.gov

Language: English
577Amines / Alcohols / Muscarinic antagonists / Duloxetine / Eli Lilly and Company / Thiophenes / Urinary retention / Adverse Event Reporting System / Serotonin–norepinephrine reuptake inhibitor / Medicine / Chemistry / Organic chemistry

Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology

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Source URL: www.fda.gov

Language: English
578Health / Drug safety / Pharmacology / Centers for Disease Control and Prevention / Public safety / Vaccine Adverse Event Reporting System / Adverse Event Reporting System / Vaccine Safety Datalink / Center for Biologics Evaluation and Research / Food and Drug Administration / Medicine / Safety

Beyond VAERS: How the FDA is doing and improving vaccine safety surveillance

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Source URL: www.fda.gov

Language: English
579Aripiprazole / Adverse Event Reporting System / Myelodysplastic syndrome / Valproic acid / Torsades de pointes / Pancytopenia / Management of schizophrenia / Liver transplantation / Jaundice / Medicine / Hematopathology / Piperazines

Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology

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Source URL: www.fda.gov

Language: English
580Medicine / Food and Drug Administration / Clinical research / Pharmaceutical industry / Epidemiology / Pharmacovigilance / Adverse Event Reporting System / Postmarketing surveillance / Adverse effect / Pharmacology / Pharmaceutical sciences / Health

FDA Science Board Subcommitte

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Source URL: www.fda.gov

Language: English
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