Comparisons of food and drug administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: Report of the international society for pharmacoeconomics and outcomes research risk benefit management working group

Value in Health

Volumn 15, Issue 8, 2012, Pages 1108-1118

  Lis, Yvonne ^a   Roberts, Melissa H ^b   Kamble, Shital ^c   Guo, Jeff J ^d   Raisch, Dennis W ^e  

^a PAREXEL INTERNATIONAL   (United States)

^b LOVELACE CLINIC FOUNDATION   (United States)

^c IQVIA   (United States)

^d UNIVERSITY OF CINCINNATI MEDICAL CENTER   (United States)

^e UNIVERSITY OF NEW MEXICO   (United States)

Author keywords

European Medicines Agency; Food and Drug Administration; Pharmaceuticals; Risk benefit management

Indexed keywords

ARTICLE; DRUG APPROVAL; DRUG INDUSTRY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HUMAN; PHARMACOECONOMICS; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; RISK MANAGEMENT;

DRUG APPROVAL; DRUG TOXICITY; ECONOMICS, PHARMACEUTICAL; EUROPE; GUIDELINES AS TOPIC; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; RISK ASSESSMENT; RISK MANAGEMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84871215172     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2012.06.019     Document Type: Article

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