Expediting drug development for serious illness: Trade-offs between patient access and certainty
Author:
Affiliation:
1. Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Springs, MD 20993, USA
Publisher
SAGE Publications
Subject
Pharmacology,General Medicine
Link
http://journals.sagepub.com/doi/pdf/10.1177/1740774518770656
Reference2 articles.
1. The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation
2. Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014
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