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

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. The GAO report notes FDA classified only 3% of clinical research inspections conducted in 2018-2020 as having serious deficiencies that could warrant regulatory action. Investigators...