FDA Announces “plausible Mechanism” Approval Pathway for Certain Personalized Therapies, With Few Details

Late on Wednesday, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and Center for Biologics Evaluation & Research (CBER) Director Vinay Prasad published an article in the New England Journal of Medicine outlining a new “plausible mechanism pathway,” under which a drug or biologic manufacturer may be able to obtain FDA marketing authorization for products targeting specific, well-understood genetic abnormalities. The approach is intended to address areas of unmet need where…
By: Hogan Lovells