An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals

Therapeutic Innovation and Regulatory Science

Volumn 49, Issue 6, 2015, Pages 831-839

  Krumholz Bahner, Stephanie ^a   Garibbo, Mimmo ^b   Getz, Kenneth A ^c   Widler, Beat E ^d  

^a NDA Regulatory Service Switzerland GmbH   (Switzerland)

^b Ethical GmbH   (Switzerland)

^c TUFTS UNIVERSITY   (United States)

^d Widler and Schiemann Ltd   (Switzerland)

Author keywords

adjudication; drug approval; EMA; FDA

Indexed keywords

ANTIVIRUS AGENT; BIOSIMILAR AGENT; CENTRAL NERVOUS SYSTEM AGENTS; NEW DRUG; NEW MOLECULAR ENTITIES; ORPHAN DRUG; UNCLASSIFIED DRUG; VACCINE;

ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; DIGESTIVE SYSTEM PERFORATION; DOCUMENTATION; DRUG APPROVAL; EUROPEAN MEDICINES AGENCY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERSTITIAL LUNG DISEASE; LABORATORY TEST; MULTIPLE SCLEROSIS; PRIORITY JOURNAL; PULMONARY HYPERTENSION; RISK ASSESSMENT; UNITED STATES;

EID: 84944680789     PISSN: 21684790     EISSN: 21684804     Source Type: Journal    
DOI: 10.1177/2168479015580382     Document Type: Article

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