A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions

Authors:

BPBruce M. Psaty
Bruce M. Psaty
EMEric M. Meslin
Eric M. Meslin
ABAlasdair Breckenridge
Alasdair Breckenridge

20 June 2012

journal article
viewpoint
Published by American Medical Association (AMA) in JAMA

Vol. 307 (23) , 2491-2492
DOI:10.1001/jama.2012.5545
PMID:22563032

Abstract

In the postmarket setting, the regulation of medicines requires an assessment of the balance between their benefits and risks and, as new information becomes av

Keywords

DRUG APPROVAL
INSTITUTE OF MEDICINE (U.S.)

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