Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration

JAMA - Journal of the American Medical Association

Volumn 318, Issue 7, 2017, Pages 626-636

  Naci, Huseyin ^a   Smalley, Katelyn R ^a   Kesselheim, Aaron S ^b  

^a LONDON SCHOOL OF ECONOMICS   (United Kingdom)

^b HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL (TOPIC); DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; HUMAN; METHODOLOGY; POSTMARKETING SURVEILLANCE; PROCEDURES; STATISTICS AND NUMERICAL DATA; TIME FACTOR; UNITED STATES;

CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; RESEARCH DESIGN; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85027882319     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2017.9415     Document Type: Article

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