FDA Issues Wave Of "Breakthrough Therapy" Denials
This article was originally published in RPM Report
Executive Summary
FDA denied 10 requests for breakthrough therapy within a four-week period. The reasons behind the wave of rejections are unclear, but may be inherent to the rollout of the program.
You may also be interested in...
Breakthrough Nears 50 Approvals: Process Improving, But “Gray Areas” Persist
Reflecting on the last three-plus years, agency officials say the quality of requests for breakthrough are improving, and review divisions outside of the initial base of oncology are becoming more comfortable with granting designations.
Breakthrough Nears 50 Approvals: Process Improving, But “Gray Areas” Persist
FDA is close to hitting a milestone in the short history of the Breakthrough Therapies designation: 50 indications approved under the abbreviated development and review pathway. In reflecting on the last three-plus years, agency officials say the quality of requests for Breakthrough are improving, and review divisions outside of the initial base of oncology are becoming more comfortable with granting designations.
Covering Breakthroughs: Payors in New Territory
FDA has granted more than two dozen “Breakthrough Therapy” designations. Not everyone is sure that’s a great thing. Payors, in particular, are getting “nervous” about what hyperfast development of hyper-expensive therapies will mean.