FDA Center for Drug Evaluation and Research’s Office of Clinical Pharmacology (OCP) Announces Availability of Updated Question-Based Review MaPP
U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Clinical Pharmacology (OCP) in the Office of Translational Sciences announces the availability of an updated manual of policies and procedures (MaPP), MaPP 4000.4 - “Good Review Practices: Clinical Pharmacology Review of New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs).” This MaPP will replace the previous MaPP 4000.4, titled “Clinical Pharmacology and Biopharmaceutics Review Template” posted as of 06/24/2004. This MaPP is commonly referred to as the Question-Based Review MaPP or “QBR MaPP.”
The QBR MaPP builds on the strengths of OCP’s previous efforts to effectively communicate regulatory and scientific issues around dosage selection and optimization, therapeutic individualization, and benefit/risk balance. It also reflects the increasing importance of mechanistic understanding and clinical pharmacology principles in drug evaluation as a key component of the evidence of effectiveness assessment.
The QBR MaPP contains:
- Guiding principles for performing integrated OCP reviews
- A general outline and specific template for integrated OCP reviews showing sections that should be included, order of content, and instructions
- A guide for labeling issue identification
- A clinical pharmacology and pharmacokinetics summary table for use in reviews
The new QBR MaPP is intended to ensure that OCP reviews convey critical information and that the narrative of OCP’s decision-making processes is conveyed in a prioritized, issue-driven, and consistent manner. This MaPP underscores OCP’s commitment to delivering an integrated clinical pharmacology review of NDAs and BLAs that synthesizes information from diverse knowledge areas including drug disposition, pharmacology, biomarkers, quantitative methods, drug safety, pharmacotherapy, and clinical trial methods.
Additional information on this new QBR MaPP may be found at http://go.usa.gov/xKePG.
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This burst was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
FDA/Center for Drug Evaluation and Research (CDER)
Office of Translational Sciences
Office of Clinical Pharmacology