Califf, biopharma industry leaders support accelerated approval reforms

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.  ...