GAO Calls On FDA To Speed Up Rulemaking On BA/BE Studies

By Jessica Karins / March 29, 2024 at 9:38 AM

Exemptions in FDA regulations for clinical studies seeking to establish bioavailability or bioequivalence of generic drugs should be closed so the agency can respond to problems uncovered in clinical research inspections, according to a report from the Government Accountability Office (GAO) that notes FDA has pushed back a proposed rulemaking on the issue several times.


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.