Posted by Michael Wonder on 23 Jun 2022
Expediency versus efficacy: re-examining the FDA’s accelerated drug approval process
23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program in response to the HIV epidemic.
The accelerated approval program is a mechanism that permits conditional approval of a new drug that treats a serious medical condition and fills an unmet need based on its impact on a surrogate outcome.
