Failed ANDA Bioequivalence Studies Haven’t Impacted Review Decisions, FDA Says

Bioequivalent studies that fail to show bioequivalence between a generic drug and its reference product have not been a factor in ANDA approvals, Barbara Davit, acting director of the Office of Generic Drugs’ Division of Bioequivalence 2, reported at the Generic Pharmaceuticals Association’s fall technical meeting on Oct. 5 in Bethesda, Md.