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Pharmaceuticals / Regulatory Affairs

FDA Proposes Eight-Month Review of Priority Generics, Plans for Wave of Biosimilars

March 9, 2017

The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics.

For GDUFA II, the agency is proposing to meet with companies ahead of submissions of complex generic products, and expects that will clarify regulatory expectations and reduce the number of review cycles before approval, down from the current median of four. The agency also committed to 10-month reviews of all ANDAs.

To help meet those commitments, the FDA is planning to restructure its Office of Regulatory Affairs in May, to include groups of facility inspectors that will only focus on pharmaceutical products, according to CDER Director Janet Woodcock, testifying before the House Energy and Commerce health subcommittee yesterday. Representatives from AAM, BIO and The Biosimilars Council also testified and agreed with the proposals.

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