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June 9, 2010

FDA Posts MAPP on Reporting Format for Nanotechnology-Related Information

Lynn L. Bergeson

On June 3, 2010, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) posted on its website a Manual of Policies and Procedures (MAPP) entitled “Reporting Format for Nanotechnology-Related Information in CMC Review.” The purpose of the MAPP is to provide chemistry, manufacturing, and controls (CMC) reviewers within OPS with the framework by which relevant information about nanomaterial-containing drugs will now be captured in CMC reviews of current and future CDER drug application submissions.  According to the MAPP, this information “will be entered into a nanotechnology database under construction and ultimately be used to develop policy regarding these products.” Information to be collected includes whether the application contains nanomaterials; what type of nanomaterial is included in the product; whether the nanomaterial is a reformulation of a previously approved product; whether the nanomaterial is part of the drug substance or the drug product; whether the particle size was described in the application and what the reported particle size is; whether the techniques used to assess particle size are thoroughly described with respect to their adequacy; whether the nanomaterial is soluble or insoluble in an aqueous environment; and what other properties of the nanomaterial were measured and reported in the application, and how those properties were measured. The MAPP was effective June 3, 2010.