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

Regulatory NewsRegulatory News
| 25 September 2019 | By Michael Mezher 

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).
Within the MAPP, FDA explains that DMEPA "holds primary responsibility for the review of HF submissions for [new drug applications] NDAs and [biologics license applications] BLAs," noting that sponsors may begin interactions with the agency concerning product design and HF validation study protocols during the pre-investigational new drug application (IND) stage.
The agency also notes that the MAPP does not apply to generic drug-device combinations submitted under an abbreviated new drug application (ANDA).
When a HF validation study protocol includes patient-oriented labeling, FDA says that DMEPA will consult with DMPP "for an expert review of the patient-oriented labeling and then send sponsors a single set of recommendations that includes recommendations from both divisions."
Under the policy the two review divisions are instructed to meet their agreed upon due dates and timeframes and follow CDER's policies for equal voice, differing professional opinions and dispute resolution if any issues are unable to be resolved between the divisions.
During the review process, FDA says the Office of Surveillance and Epidemiology (OSE) safety regulatory project manager (SRPM) will serve as the point of contact both for DMPP and for the sponsor, whereas the Office of Medical Policy (OMP) DMPP reviewer is tasked with reviewing patient-oriented labeling and responding to the intra-center consult from DMEPA.
The MAPP goes on to detail the process for initiating a patient-oriented labeling consult, carrying out the review and consultation, as well as additional tasks and responsibilities for staff to complete as part of the review.
The MAPP was published internally on 18 September 2019 and is effective immediately.


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