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.
