OCP IND Prioritization, Triage Guidance

CDER has issued an updated Office of Clinical Pharmacology (OCP) Manual of Policies and Procedures (MAPP), “OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs,” with good review management principles and practices for submissions during the IND phase of drug development. The MAPP says it promotes excellence in scientific reviews and provides a consistent approach to the conduct of the IND review process in conjunction with the policies of the Office of New Drugs and other CDER stakeholders.

CDER says that since the MAPP was originally published in 2006, the Center and OCP have undergone significant structural changes to their organizations, and have seen increases in the volume and variety of submissions. The update provides contemporary expectations for the fundamental values of good review principles to maximize the efficiency and transparency of OCP’s IND review processes, CDER says.