Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs

Health Affairs

Volumn 34, Issue 4, 2015, Pages 681-688

  Ross, Joseph S ^a   Dzara, Kristina ^a   Downing, Nicholas S ^b  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b YALE NEW HAVEN HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG; ORPHAN DRUG;

ARTICLE; CARCINOGENICITY; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); DRUG ANALYSIS; DRUG APPROVAL; DRUG EFFICACY; DRUG LABELING; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; DRUG TOXICITY; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; INTENTION TO TREAT ANALYSIS; PHASE 3 CLINICAL TRIAL (TOPIC); POSTMARKETING SURVEILLANCE; DRUG SCREENING; PATIENT SAFETY; PROCEDURES; QUALITATIVE RESEARCH; STANDARDS; UNITED STATES;

DRUG APPROVAL; DRUG EVALUATION; INVESTIGATIONAL NEW DRUG APPLICATION; PATIENT SAFETY; QUALITATIVE RESEARCH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84929623859     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2014.1160     Document Type: Article

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