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# MAPP on Patient-Oriented Labeling Consults
- URL: https://www.fdaweb.com/mapp-on-patient-oriented-labeling-consults/
- Published: 2019-09-24T12:00:00.000Z
- Updated: 2026-09-15T01:52:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145076

CDER has issued a Manual of Policies and Procedures (MAPP) outlining the process to be followed when the Division of Medication Error Prevention consults the Division of Medical Policy Programs for review of patient-oriented labeling for drug products that are intended for use by patients, caregivers, or both. The [MAPP](https://www.fda.gov/media/131008/download?ref=fdaweb.com) applies to proposed patient-oriented labeling submitted as part of human factors validation study protocols evaluated under the jurisdiction of CDER or consulted to CDER from CBER. It fulfills a PDUFA 6 performance goal of ensuring efficient, effective, and consistent combination product development and review as it relates to patient-oriented labeling, including instructions for use materials, for those drug-device and biologic-device combination products regulated by CDER and CBER.