June 25, 2022

Volume XII, Number 176

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FDA Publishes Final Guidance for Industry on Drug Products, Including Biological Products, that Contain Nanomaterials

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).

©2022 Bergeson & Campbell, P.C.National Law Review, Volume XII, Number 115
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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

202-557-3809
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