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Association between preapproval confirmatory trial initiation and conversion to traditional approval or withdrawal in the FDA accelerated approval pathway

Shahzad, Mahnum, Naci, Huseyin and Wagner, Anita K. (2023) Association between preapproval confirmatory trial initiation and conversion to traditional approval or withdrawal in the FDA accelerated approval pathway. JAMA, 329 (9). 760 - 761. ISSN 0098-7484

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Identification Number: 10.1001/jama.2023.0625

Abstract

The accelerated approval pathway allows the US Food and Drug Administration (FDA) to approve drugs that demonstrate an effect on a surrogate end point that is reasonably likely to predict clinical benefit. Following accelerated approval, manufacturers are required to verify clinical benefit in confirmatory trials. Delays in confirmatory trial completion have led to proposals for reforming the accelerated approval pathway.1 One proposal would require a confirmatory trial initiation prior to accelerated approval.2 An FDA analysis found an association between preapproval initiation and faster (from the date of accelerated approval) completion of confirmatory trials for oncology indications that ultimately received traditional approval or were withdrawn.3 We extended the FDA analysis by also including nononcology indications and evaluating whether preapproval initiation was associated with timelier conversion to traditional approval or withdrawal.

Item Type: Article
Official URL: https://jamanetwork.com/journals/jama
Additional Information: © 2023 American Medical Association
Divisions: Health Policy
Subjects: R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine
R Medicine > R Medicine (General)
R Medicine > RS Pharmacy and materia medica
Date Deposited: 24 Mar 2023 12:12
Last Modified: 27 Feb 2024 21:51
URI: http://eprints.lse.ac.uk/id/eprint/118505

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