Author: [AUTHOR] Published on 4/7/2023 5:00:00 AM
FDA’s Office of Clinical Pharmacology Announces Updated MAPP on Prioritization, Triage, and Review Processes for Investigational New Drugs
On April 3, 2023, the US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP) announced the availability of an updated manual of policies and procedures (MAPP) entitled
OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs: MAPP 5100.3 Revision 1. This MAPP outlines for review staff within OCP good review management principles and practices for submissions during the investigational new drug application (IND) phase of drug development, promotes excellence in scientific reviews, and provides a consistent approach to the conduct of the IND review process in conjunction with the policies of other stakeholders within CDER.
The scope of this MAPP is OCP’s policy and procedures for prioritization of IND submissions for review, conduct of review, and documentation of review findings. The
OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs: MAPP 5100.3 Revision 1 replaces MAPP 5100.3, which published in 2006. Since this MAPP was initially published, CDER and OCP have undergone significant structural changes to their organizations, as well as seen increases in the volume and variety of submissions, processes, and evaluation approaches. This updated MAPP provides contemporary expectations for the fundamental values of good review principles to maximize the efficiency and transparency of OCP’s IND review processes.
CDER's MAPPs are federal directives and documentation of internal policies and procedures. MAPPs are required by law and made available to the public to make CDER a more transparent organization. CDER updates MAPPs periodically. For the most recent version of a MAPP, check the FDA web page
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.