Characteristics of clinical studies used for US Food and Drug Administration approval of high-risk medical device supplements

JAMA - Journal of the American Medical Association

Volumn 318, Issue 7, 2017, Pages 619-625

  Zheng, Sarah Y ^a   Dhruva, Sanket S ^b,c   Redberg, Rita F ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b ROBERT WOOD JOHNSON FOUNDATION   (United States)

^c VA CONNECTICUT HEALTHCARE SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL (TOPIC); DEVICE APPROVAL; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; MALE; METHODOLOGY; MIDDLE AGED; STANDARDS; STATISTICS AND NUMERICAL DATA; UNITED STATES;

CLINICAL TRIALS AS TOPIC; DEVICE APPROVAL; FEMALE; HUMANS; MALE; MIDDLE AGED; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85027831089     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2017.9414     Document Type: Article

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