USA – New MAPP Offers Insight Into Patient-Oriented Labeling Consultations for Combination Products

The US Food and Drug Administration (FDA) on Monday issued a new Manual of Policies and Procedures (MAPP) detailing the agency’s internal procedures for patient-oriented labeling reviews for combination products between two divisions at the agency.

Specifically, the MAPP covers consultation procedures between the Division of Medication Error Prevention and Analysis (DMEPA) and the Division of Medical Policy Programs (DMPP) for reviewing patient-oriented labeling submitted with human factors (HF) validation study protocols submitted to the Center for Drug Evaluation and Research (CDER) or to the Center for Biologics Evaluation and Research (CBER) and passed on to CDER for review.

FDA says the MAPP fulfills a performance goal under the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI) for « ensuring the efficient, effective and consistent combination product development and review. » In this context, FDA says that patient-oriented labeling includes approved patient instructional materials such as instructions for use (IFUs) and quick reference guides (QRGs)…