Senate Appropriators Worry About US FDA Gene Therapy, Complex Generic Approval Pace

In report language, the committee funds more CBER cell and gene therapy staff for rare diseases and suggests AI be considered to speed up complex generic assessments.

Artificial Intelligence — Senators want the FDA to consider artificial intelligence to help find complete generic application deficiencies quicker. • Source: Alamy

Senators want the US Food and Drug Administration to work faster on cell and gene therapy issues to remain a world leader, as well as fulfill patient needs.

An additional $5m was allocated to the Center for Biologics Evaluation and Research in the fiscal year 2022 Senate...