Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

Therapeutic Innovation and Regulatory Science

Volumn 48, Issue 2, 2014, Pages 200-207

  Archdeacon, Patrick ^a   Grandinetti, Cheryl ^a   Vega, José M ^b   Balderson, David ^b   Kramer, Judith M ^c  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b AMGEN INC   (United States)

^c DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

clinical trials; reporting; safety

Indexed keywords

ARTICLE; BIOSTATISTICS; BIOTECHNOLOGY; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG INDUSTRY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; MEDICAL PRACTICE; ORGANIZATIONAL STRUCTURE; PRIORITY JOURNAL;

EID: 84895428122     PISSN: 21684790     EISSN: 21649200     Source Type: Journal    
DOI: 10.1177/2168479013509382     Document Type: Article

References (12)

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