FDA exploring path forward for therapies that received CRLs

FDA is exploring potential paths forward for companies that recently received complete response letters, according to individuals briefed on the discussions and public records. The outreach comes amid a coordinated pressure campaign involving sponsors, patient advocates, members of Congress, and conservative media.

The flurry of activity around CRLs follows news of Vinay Prasad’s resignation as director of the Center for Biologics Evaluation and Research and as FDA’s CSO/CMO. Prasad has consistently opposed accelerated approval based on surrogate endpoints and called for more stringent efficacy standards. ...