Comparison of drug approvals in Europe versus the United States: An analysis of discrepancies between drug products reviewed by EMA and FDA

Therapeutic Innovation and Regulatory Science

Volumn 48, Issue 3, 2014, Pages 362-366

  Makuch, Robert W ^a   Shi, Ruizhi ^a  

^a YALE UNIVERSITY   (United States)

Author keywords

Drug approval; EMA; FDA; Regulatory affairs

Indexed keywords

CERTOLIZUMAB PEGOL; GEMTUZUMAB OZOGAMICIN; IXABEPILONE; LASOFOXIFENE; MIFAMURTIDE; MILNACIPRAN; NEW DRUG; PIRFENIDONE; SITAXSENTAN; SUGAMMADEX; TRABECTEDIN; GALYUS; TEDAPTIVE; UNCLASSIFIED DRUG; ZEVASCA;

ACUTE GRANULOCYTIC LEUKEMIA; ARTICLE; AUTHORITY; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; EUROPE; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HUMAN; LIVER TOXICITY; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; RISK BENEFIT ANALYSIS; TELECONFERENCE; UNITED STATES; COMPARATIVE STUDY; DRUG MANUFACTURE; DRUG MARKETING; DRUG QUALITY;

EID: 84905105962     PISSN: 21684790     EISSN: 21684804     Source Type: Journal    
DOI: 10.1177/2168479013517103     Document Type: Article

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