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December 18, 2017

Bloomberg BNA Daily Environment Report Includes Comments by Lynn L. Bergeson Regarding FDA Draft Guidance for Nanomaterial Drugs

The ACTA Group

On December 18, 2017, Lynn L. Bergeson, President of The Acta Group (Acta®), was quoted by the Bloomberg BNA Daily Environment Report in the article “FDA Pushes Risk-Based Approach to Nanomaterial Drugs.”

Developers of drugs containing nanomaterials—substances so small they can’t be seen with a regular microscope—got some advice on how to assess their risks in FDA draft guidance issued Dec. 15.


Without having read it in detail yet, Lynn Bergeson, managing partner of Bergeson & Campbell PC, told Bloomberg BNA in a Nov. 15 email the FDA “has done its characteristic good job of providing useful and user-friendly information to stakeholders innovating and manufacturing drug and biological products containing nanomaterials.”

“The [g]uidance provides significant granularity on technical and scientific issues, including nanomaterial characterization methods, [absorption, distribution, metabolism, and excretion] considerations, risk considerations for specific routes of exposure, among other topics,” said Bergeson, whose firm includes a nanotechnology practice. The document “would appear to join a long line of useful FDA guidance documents around the issue of nanotechnology and the use of nanomaterials in FDA[-] regulated products.”


“FDA’s customary caveats,” Bergeson said, “are noted in the guidance, reassuring stakeholders that these important bedrock principles are unchanged.”

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