The US Food and Drug Administration's expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation

Clin Trials. 2018 Jun;15(3):243-246. doi: 10.1177/1740774518770657.

Authors

Joshua D Wallach¹, Joseph S Ross², Huseyin Naci³

Affiliations

¹ 1 Collaboration for Research Integrity and Transparency, Yale School of Medicine, New Haven, CT, USA.
² 2 Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
³ 3 LSE Health, Department of Health Policy, The London School of Economics and Political Science, London, UK.

PMID: 29871507
DOI: 10.1177/1740774518770657

No abstract available

Keywords: The US Food and Drug Administration; drug policy; expedited approval; pharmaceutical regulation; postmarketing requirements.

Publication types

Research Support, Non-U.S. Gov't
Comment

MeSH terms

Drug Approval*
Product Surveillance, Postmarketing*
United States
United States Food and Drug Administration