Bloomberg BNA Daily Environment Report Includes Comments by Lynn L. Bergeson Regarding FDA Draft Guidance for Nanomaterial Drugs
On December 18, 2017, Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), 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so small they can't be seen with a regular microscope—got some advice on how to assess their risks in FDA draft guidance issued Dec. 15.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.”