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

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.

Comment

Joshua D Wallach et al. Clin Trials. 2018 Jun.

. 2018 Jun;15(3):243-246.

doi: 10.1177/1740774518770657.

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.

No abstract available

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

Comment on

Access versus evidence: The regulators' dilemma.
Schilsky RL. Schilsky RL. Clin Trials. 2018 Jun;15(3):240-242. doi: 10.1177/1740774518770660. Clin Trials. 2018. PMID: 29871504 No abstract available.
Expedited and facilitated drug evaluations and evidence of benefit and risk: The cup is half-full.
Califf RM. Califf RM. Clin Trials. 2018 Jun;15(3):235-239. doi: 10.1177/1740774518771347. Clin Trials. 2018. PMID: 29871505 No abstract available.
Expediting drug development for serious illness: Trade-offs between patient access and certainty.
Woodcock J. Woodcock J. Clin Trials. 2018 Jun;15(3):230-234. doi: 10.1177/1740774518770656. Clin Trials. 2018. PMID: 29871508 No abstract available.
The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.
Wallach JD, Ross JS, Naci H. Wallach JD, et al. Clin Trials. 2018 Jun;15(3):219-229. doi: 10.1177/1740774518770648. Clin Trials. 2018. PMID: 29871509