ARTICLE | Regulation

Califf, biopharma industry leaders support accelerated approval reforms

Califf, GSK’s Barron, BIO’s McMurry-Heath say centralized data collection is needed

January 12, 2022 1:49 AM UTC

Rob Califf, President Joe Biden’s nominee for FDA commissioner, has publicly endorsed the accelerated approval pathway, called for redoubling efforts to confirm clinical efficacy, and backed the creation of a centralized system to generate evidence about drugs that receive accelerated approval.

Speaking at a meeting convened on Jan. 9 by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), Califf also encouraged Congress to create a legislative framework to support evidence collection, and advocated tighter integration of FDA regulatory decisions with decisions made by physicians and payers.  ...