Priority review drugs approved by the FDA and the EMA: Time for international regulatory harmonization of pharmaceuticals?

Pharmacoepidemiology and Drug Safety

Volumn 24, Issue 7, 2015, Pages 709-715

  Alqahtani, Saad ^a   Seoane Vazquez, Enrique ^a,b   Rodriguez Monguio, Rosa ^c   Eguale, Tewodros ^a,b,d  

^a MASSACHUSETTS COLLEGE OF PHARMACY AND HEALTH SCIENCES   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c UNIVERSITY OF MASSACHUSETTS   (United States)

^d MCGILL UNIVERSITY   (Canada)

Author keywords

Drug indication; Drug regulation; European Medicines Authority (EMA); Food and Drug Administration (FDA); Marketing approval; Pharmacoepidemiology; Priority review

Indexed keywords

ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; CARDIOVASCULAR AGENT; CENTRAL NERVOUS SYSTEM AGENTS; GASTROINTESTINAL AGENT; IMMUNOMODULATING AGENT; INSULIN DERIVATIVE; ORPHAN DRUG; RESPIRATORY TRACT AGENT; SEX HORMONE;

ARTICLE; DRUG APPROVAL; DRUG CLASSIFICATION; DRUG CONTRAINDICATION; DRUG INDICATION; DRUG INFORMATION; DRUG LEGISLATION; DRUG MARKETING; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL; EUROPE; GOVERNMENT REGULATION; INTERNATIONAL COOPERATION; LEGISLATION AND JURISPRUDENCE; ORGANIZATION AND MANAGEMENT; STATISTICS AND NUMERICAL DATA; UNITED STATES;

DRUG APPROVAL; EUROPE; GOVERNMENT REGULATION; INTERNATIONAL AGENCIES; INTERNATIONAL COOPERATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84933672548     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3793     Document Type: Article

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