Regulatory Focus™ > News Articles > Revised FDA Manual Provides Statistical Reviewers with Standardized Template

Revised FDA Manual Provides Statistical Reviewers with Standardized Template

Posted 02 August 2012 | By Alexander Gaffney, RAC 

A revised Manual of Policies and Procedures (MAPP) developed for US Food and Drug Administration (FDA) drug review staff instructs them on how to assess statistical reviews using good review practices (GRPs) using a standardized review template.

The MAPP, Good Review Practice: Statistical Review Template, specifically applies to employees within the Center for Drug Evaluation and Research's (CDER) Office of Translational Sciences (OTS)-an office charged with promoting, "Efficient and informative study designs and data analysis methods to quantitatively evaluate the efficacy, safety and dosing of drugs."

The GRP MAPP establishes documentation procedures for reviewing new drug and biologics license applications (NDAs/BLAs), as well as amendments and efficacy supplements submitted by the application sponsor. Each reviewer is tasked with analyzing his or her section of an application, forming an opinion and sharing it with the broader review team for that particular application.

To do so, reviewers must use a standardized statistical review template to promote GRPs and make it easier for supervising staff to analyze staff opinions. The review template is also capable of accommodating dissent among statistical reviewers. In such cases, FDA instructs team leaders to, "Encourage the statistical reviewer to document his or her own conclusions and recommendations in the statistical review," before writing up his or her own analysis and conclusion.

The standardized review template replaces an earlier version first released in 2005, and FDA notes it combines both the NDA and BLA MAPPs that previously existed separately. Other changes, it explains, are mostly organizational in nature.

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