OND Consultative Review MAPP

CDER has issued a Manual of Policies and Procedures (MAPP) on clinical consultative review of drugs regulated within the Office of New Drugs (OND). The document describes the clinical consultative review process for INDs, NDAs, BLAs, and supplemental NDAs and BLAs. The procedures “are intended to ensure quality and consistency in clinical consultative reviews,” the MAPP says, and also describe the sign-off policies and procedures for the applications for drugs regulated in OND that require consults from other divisions or offices within OND.

The document says that applications for drugs regulated in OND are assigned to specific subject matter review divisions by indication. However, the evaluation of a submission often requires the expertise of a second review division or a second OND office because of that division’s or office’s familiarity with the drug for other uses or because of its expertise in another aspect of the disease or involved organ system.