Challenges for the FDA The Future of Drug Safety Workshop Summary Forum on Drug Discovery Development and Translation 1st Edition by Leslie A Pray, Sally Robinson ISBN 0309109876 9780309109871

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ISBN 10: 0309109876 
ISBN 13: 9780309109871
Author: Leslie A Pray, Sally Robinson

As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA’s reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA’s Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children.

Challenges for the FDA The Future of Drug Safety Workshop Summary Forum on Drug Discovery Development and Translation 1st Table of contents:

1 Introduction    9-12    
2 Addressing the FDA’s Resource Challenges    13-18    
3 Strengthening the Scientific Base of the Agency    19-25    
4 Integrating Pre- and Postmarket Review    26-31    
5 Enhancing Postmarket Safety Monitoring    32-48    
6 Conducting Confirmatory Drug Safety and Efficacy Studies    49-53    
7 Enhancing the Value of Clinical Trial Registration    54-57    
8 Enhancing Postmarket Regulation and Enforcement    58-69    
9 Looking to the Future    70-77

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Tags: Leslie A Pray, Sally Robinson, FDA, Drug Safety, Summary Forum, Discovery Development