Association of expedited review programmes with postmarketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017

ABSTRACT:

Objective

To explore the associations between the risks of postmarketing safety events of new drugs and the four expedited programmes of priority review, accelerated approval, fast track and breakthrough therapy established by the US Food and Drug Administration (FDA); and to investigate whether multiple uses of expedited programmes, and the combinations of expedited programmes with orphan designation, were relevant to different safety profiles.

Design

Cohort study.

Setting

USA.

Participants

All new drugs approved by the FDA between 1 January 2007 and 31 December 2017, followed up until 10 April 2021.

Outcome measures

Safety events included safety-related withdrawal, new boxed warning, drug safety communication, postapproval risk evaluation miti

SUBMITTER: Zhu X 

PROVIDER: S-EPMC9301790 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature