FDA Will Publish Draft Guidance on Drug Products, Including Biological Products, that Contain Nanomaterials
The Food and Drug Administration (FDA) is scheduled to publish a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.” According to the pre-publication version of the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, that contain nanomaterials. The draft guidance applies to human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The notice states that the draft guidance discusses both general principles and specific considerations for the development of drug products containing nanomaterials, including considerations for establishing the equivalence of such products with other drugs. The draft guidance discusses considerations for quality, nonclinical, and clinical studies as they relate to drug products containing nanomaterials throughout product development and production. The draft guidance does not limit or classify the types of nanomaterials that can be used in drug products. Instead it focuses on the “deliberate and purposeful manipulation and control of dimensions to produce specific physicochemical properties” that may warrant further evaluation with regards to safety, effectiveness, performance, and quality. FDA notes that the draft guidance “does not address, or presuppose, what ultimate regulatory outcome, if any, will result for a particular drug product that contains nanomaterials.” FDA currently addresses issues such as the safety, effectiveness, public health impact, or the regulatory status of drug products that contains nanomaterials on a case-by-case basis using its existing review processes. FDA states that it may continue to develop guidance addressing “certain specific commonly-used types of nanomaterials, e.g., some liposomes, to better address the challenges in evaluating and characterizing the quality and performance of drug products that incorporate them.” The draft guidance includes recommendations for applicants and sponsors of investigational, premarket, and postmarket submissions for these products. Publication of the draft guidance will begin a 90-day comment period. FDA seeks comment on the terminology, including the term “nanomaterial,” as used in the draft guidance.