Integrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost.
JournalJAMA Internal Medicine
PublisherAmerican Medical Association
MetadataShow full item record
DescriptionViewpoint 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.
individual scientific reviews
integrated drug reviews
United States. Food and Drug Administration
Identifier to cite or link to this itemhttp://hdl.handle.net/10713/12226