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Insight & Intelligence : Nov 2, 2011
FDA Evaluating Input from Industry on Nanotech Guidance
Questions and comments covered FDA’s definitions of what constitutes a nanomaterial.!--h2>
Biotechnology companies have expressed general support for FDA’s draft guidance defining whether products contain nanomaterials or otherwise involve the application of nanotechnology. But the sector also made its case for less red tape and more leeway, raising issue with some specifics and asking for clarity on other topics.
A Matter of Size
During FDA’s comment period, the Biotechnology Industry Organization (BIO) suggested addressing agglomerates or aggregates by maintaining the draft guidance’s 100 nm upper limit but for larger nanomaterials and nanomaterial formations, by specifying properties or phenomena that differ from those of conventionally scaled material.
BIO also wants FDA to include biopersistence as a key criterion for defining nanomaterials. Additionally, it asked the agency to exempt from the guidance inert ingredients that meet the requirements for nanotechnology, such as lubricants, binders, fillers, disintegrants, colorants, buffering agents, and coatings. It also asked the agency to clarify the scope of pharmaceutical products involving nanotech that would be subject to the guidance.
Policy and Funding
While FDA weighs comments on which FDA-regulated products should be considered as involving nanotech, two Senators are seeking final say on a bill to help FDA better regulate the technology. On October 6, Sen. Mark Pryor (D-AR) introduced the Nanotechnology Regulatory Science Act of 2011. The measure (S.1662) would direct FDA to develop safety regulations for companies using nanotech.
Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.
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