US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.

ABSTRACT:

Background/aims

The US Food and Drug Administration outlines clinical studies as postmarketing requirements and commitments to be fulfilled following approval of new drugs and biologics ("therapeutics"). Regulators have increasingly emphasized lifecycle evaluation of approved therapeutics, and postmarketing studies are intended to advance our understanding of therapeutic safety and efficacy. However, little is known about the indications that clinical studies outlined in postmarketing requirements and commitments investigate, including whether they are intended to generate evidence for approved or other clinical indications. Therefore, we characterized US Food and Drug Administration postmarketing requirements and commitments for new therapeutics approved from 2009 to 2018.

Meth

SUBMITTER: Skydel JJ 

PROVIDER: S-EPMC8292154 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature