FDA Seeks Input on Makary's Pilot Drug Approval Accelerator

FDA seeks input on Makary's pilot drug approval accelerator

The FDA is seeking feedback ahead of a public meeting this summer to evaluate the progress of a voucher pilot that has so far accelerated four drug approvals. Created last June, the

FDA’s New Program Injects Politics Into Drug Approval

A new program at the federal Food and Drug Administration (FDA) promises ultra-fast drug approvals for companies whose products align with White House policy priorities. The initiative could accelerate the approval of certain treatments dramatically – but it also raises an important question: should political priorities influence which drugs receive the fastest regulatory review?  In my piece in last Sunday’s Worcester Telegram & Gazette, I expl…