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dc.contributor.authorHerder, Matthew
dc.contributor.authorMorton, Christopher J.en_US
dc.contributor.authorDoshi, Peteren_US
dc.date.accessioned2020-03-16T14:27:53Z
dc.date.available2020-03-16T14:27:53Z
dc.date.issued2020-03-02
dc.identifier.urihttp://hdl.handle.net/10713/12226
dc.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.en_US
dc.description.urihttps://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2762578en_US
dc.language.isoen_USen_US
dc.publisherAmerican Medical Associationen_US
dc.relation.ispartofJAMA Internal Medicineen_US
dc.subjectFDAen_US
dc.subjectindividual scientific reviewsen_US
dc.subjectintegrated drug reviewsen_US
dc.subject.lcshUnited States. Food and Drug Administrationen_US
dc.titleIntegrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost.en_US
dc.typeArticleen_US
dc.identifier.doi10.1001/jamainternmed.2020.0074
dc.identifier.pmid32119058
dc.identifier.ispublishedYesen_US
dc.source.journaltitleJAMA internal medicine
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