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US: FDA finalizes guidance for drugs and biologics containing nanomaterials

2022/04/27  US FDA

FDA is announcing the availability of a guidance for industry entitled “Drug Products, Including Biological Products, That Contain Nanomaterials.” This guidance applies to human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. This guidance discusses both general principles and specific considerations for developing drug products containing nanomaterials through abbreviated pathways. Considerations for quality, nonclinical, and clinical studies are discussed as they relate to drug products containing nanomaterials throughout product development and production.

This guidance finalizes the draft guidance issued December 18, 2017 (82 FR 60019). There were two noteworthy changes made from the draft version to 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, several revisions were made to reflect FDA’s current thinking with respect to abbreviated applications, including abbreviated new drug applications (ANDAs), for products containing nanomaterials. In addition to changes in response to comments, the final guidance document’s discussion regarding over-the-counter (OTC) monograph drugs has been updated for consistency with the enactment of OTC reform provisions of the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136).

This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Drug Products, Including Biological Products, That Contain Nanomaterials.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

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