Woodcock Says 505(b)(2) Filers Need Not Reference ‘Most Similar’ Listed Drug

Drugmakers filing 505(b)(2) applications are not required to reference the “most similar” listed drug as long as they can prove reliance on the chosen listed drug is scientifically justified, CDER Director Janet Woodcock says. In denying two citizen petition requests to refuse certain 505(b)(2) applications for buprenorphine/naloxone drug products, Woodcock says choosing to rely on the listed drug most similar to a proposed product would require less data to support the differences between the two, but it is not “a statutory or regulatory requirement.”
Drug Industry Daily