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November 2nd, 2011
Biotechnology companies have expressed general support for FDA's draft guidance defining whether products contain nanomaterials or otherwise involve the application of nanotechnology.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.
Questions and suggestions were sent to FDA during the 60-day comment period that followed release of the draft guidance "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology." FDA has ended its comment period, spokeswoman Erica Jefferson told GEN, but she couldn't offer a timeframe for issuance of the final guidance.
While the agency is evaluating responses on what to consider as nanomaterials, two Senators and the Obama administration, this month, called for new efforts to address safety. Finding money to support increased regulatory activities will be key to the success of these legislative efforts.
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