Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies

PURPOSE: To evaluate the advantages and disadvantages of pre-approval requirements for safety data to detect cardiovascular (CV) risk contained in the December 2008 U.S. Food and Drug Administration (FDA) guidance for developing type 2 diabetes drugs compared with the February 2008 FDA draft guidanc...

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Salvato in:
Dettagli Bibliografici
Pubblicato in:Pharmacoepidemiol Drug Saf
Autori principali: Chawla, Anita J, Mytelka, Daniel S, McBride, Stephan D, Nellesen, Dave, Elkins, Benjamin R, Ball, Daniel E, Kalsekar, Anupama, Towse, Adrian, Garrison, Louis P
Natura: Artigo
Lingua:Inglês
Pubblicazione: BlackWell Publishing Ltd 2014
Soggetti:
Original Reports
Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC4285165/
https://ncbi.nlm.nih.gov/pubmed/24892175
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/pds.3559
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