Revamping Fast-Track Approval: FDA 2023 Policy Changes Explained

Proposals to revamp the FDA’s accelerated approval pathway and boost diversity in clinical trials saw steps toward passage Tuesday by hitching a ride on a sweeping government spending package proposal.

The 4,155 page, $1.7 trillion funding bill, which is expected to get votes in both chambers and be signed by President Joe Biden by Friday, includes roughly $3.5 billion in discretionary funding for the FDA for fiscal 2023. The appropriated funding, which together with industry user fees gives the FDA a total budget of roughly $6.6. billion, is accompanied by several policy changes to boost the agency’s oversight over ...