Drugs

Office of Clinical Pharmacology Good Review Practices

CDER has issued a Manual of Policies and Procedures (MAPP) for clinical pharmacology review of NMEs, NDAs, and BLAs. The document and its attachments establish good review practices for the three categories of reviews and is one in a series of MAPPs intended to document good review practices for review staff.

The MAPP says that Office of Clinical Pharmacology (OCP) reviews of the three types of applications are expected to synthesize information from all relevant clinical pharmacology knowledge areas including drug disposition, pharmacology and biomarkers, quantitative methods, drug safety, pharmacotherapy, and clinical trial methods to inform regulatory decisions.

“The OCP review is issue-driven and assesses information in the applicant’s submission along with previously established knowledge to address issues of dose selection and optimization, therapeutic individualization, and benefit/risk balance (typically in subpopulations),” the document says. “The review also identifies any critical gaps in the understanding of conditions for optimal therapeutic use, and recommends studies that can practically address those gaps. OCP recommendations are guided by established and evolving regulatory policies and practices.”

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