The U.S. Food and Drug Administration (FDA) announced on April 22, 2022, the availability of a final guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.” 87 Fed. Reg. 24169. FDA states that the guidance applies to human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The guidance discusses both general principles and specific considerations for developing drug products containing nanomaterials through abbreviated pathways, as well as considerations for quality, nonclinical, and clinical studies as they relate to drug products containing nanomaterials throughout product development and production.
FDA issued a draft version of the guidance on December 18, 2017. According to FDA, it made two “noteworthy” changes from the draft version to the final guidance in response to stakeholder comments. First, the final guidance provides a glossary of terminology to assist in understanding how important terms are used in the document. Second, FDA made several revisions to reflect FDA’s current thinking with respect to abbreviated applications, including abbreviated new drug applications (ANDA), for products containing nanomaterials. In addition to changes in response to comments, FDA notes that it updated the final guidance document’s discussion regarding over-the-counter (OTC) monograph drugs for consistency with the enactment of OTC reform provisions of the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136).