Posted by Michael Wonder on 13 Aug 2021
Congress should fix FDA’s accelerated approval program for the next 30 years
12 August 2021 - The FDA's approval of the Alzheimer’s drug Aduhelm has sparked a broader debate on the merits and limitations of the FDA’s accelerated approval program. This debate — and its timing — are important.
The FDA issued its accelerated approval regulation nearly 30 years ago, and has since applied this approach for more than 200 new drug indications.
