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CMC GUIDANCES ON ROLLING SUBMISSIONS,

This article was originally published in The Gold Sheet

Executive Summary

...pre-marketing meetings, and IND information are being considered at FDA. The three-tiered guidance approach to jump-start the NDA/BLA review process was proposed at a recent FDA/industry workshop on CMC filings. The workshop focused on the challenges involved in refining a "rolling submission" system under which firms would submit "reviewable units" of CMC data to FDA prior to completion of the full NDA/BLA. In view of the workshop recommendations, FDA is also considering ways to make pre-marketing CMC meetings with industry more fruitful and to clarify IND filing requirements at Phase II/III.
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