Association of Advisory Committee Votes With US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021.

ABSTRACT:

Importance

The US Food and Drug Administration (FDA) often relies on independent advisory committees when making decisions about the approval of prescription drugs or their withdrawal from the market. These committees provide the FDA with valuable insight and an opportunity to build public trust through transparent deliberation, but recent controversies have raised questions about the optimal use of FDA advisory committees.

Objective

To assess the frequency, purposes, and voting outcomes of human drug advisory committees convened from 2010 to 2021 and the FDA's corresponding actions.

Design, setting, and participants

This qualitative study used a manual review of meeting summaries prepared by FDA staff for the 18 human drug advisory committees active at any time from

SUBMITTER: Daval CJR 

PROVIDER: S-EPMC10329213 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature