Integrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost.
Advisor
Date
2020-03-02
Embargo until
Language
Book title
Publisher
American Medical Association
Peer Reviewed
Type
Article
Research Area
Jurisdiction
Collections
Other Titles
Abstract
Data Availibility
Data / Code Location
Table of Contents
Description
Viewpoint article discussing the FDA’s June 2019 announcement regarding its intention to replace individual scientific reviews with integrated drug reviews for new drugs. The authors express concerns over the loss of critical data as well as the legal ramifications associated with a 2007 Congressional law and the FDA’s own Equal Voice Initiative instituted in 2008.
Citations
Altmetric: