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Pharmaceuticals / Submissions and Approvals

FDA Tech Team Designed to Foster Cutting-Edge Drugmaking, Agency Says

Oct. 3, 2017

Drugmakers wishing to use emerging manufacturing technology should ask to participate in an FDA program designed to help them through the approval process for new medicines, the agency said in finalizing draft guidance issued in 2015.

Before filing new drug applications, sponsors can submit questions and proposals to CDER’s Emerging Technology Team, which is charged with promoting adoption of new technology that can streamline production and improve quality.

The team can work to overcome delays due to a lack of familiarity with new manufacturing technology on the part of the agency’s staff, the guidance said.

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