Drug Safety and Pharmacovigilance
FEATURED REPORTS
WHAT'S NEW
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Designing a comprehensive cardiovascular safety testing regimen
by Covance Inc.
White paper
In this white paper, Covance Inc. discusses the need for a careful analysis of any medicine's impact on cardiac safety, to avoid unanticipated and hazardous effects on the heart.
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Drug Safety: Improvement needed in FDA’s Postmarket decision-making and ...
by U.S. Government Accountability Office
White paper
This white paper by United States Government Accountability Office discusses the improvement needed in FDA’s postmarket decision making and oversight process.
REPORTS BY SUBTOPIC
Designing a comprehensive cardiovascular safety testing regimen
By Covance Inc.
White paper
In this white paper, Covance Inc. discusses the need for a careful analysis of any medicine's impact on cardiac safety, to avoid unanticipated and hazardous effects on the heart.
Drug Safety: Improvement needed in FDA’s Postmarket decision-making and ...
By U.S. Government Accountability Office
White paper
This white paper by United States Government Accountability Office discusses the improvement needed in FDA’s postmarket decision making and oversight process.
Vaccine Safety: An FDA Perspective
By FDA Center for Biologics Evaluation and Research
White paper
This paper by the FDA CBER describes the major components of FDA’s evaluation of a biologics license application for a preventive vaccine, discuss the sources of data that FDA uses to monitor vaccine safety after licensure, and describe interactions between FDA and other governmental agencies in vaccine safety and other vaccine-related activities.
Guidance for Industry Safety Testing of Drug Metabolites
By FDA Center for Drug Evaluation and Research
White paper
This FDA CDER guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated.
