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Seen as a “significant step towards integrating continuous manufacturing into pharmaceutical production,” FDA approved, for the first time, a request to change a facility’s production from batch to continuous manufacturing in early April. The approved change is for HIV-1 treatment Prezista, made by Janssen Pharmaceuticals. At the May GPhA CMC Workshop, OPQ Emerging Technology Team Chair Larry Lee noted that the supplement was approved a week before the user fee deadline, reflecting the support of the team for these technology advancements. CDER approved an NDA for Vertex’s oral solid Orkamb using continu- ous manufacturing in July 2015. [See IPQ Feburary/March 2106 Monthly Update for a review of how CDER is supporting contin- uous manufacturing as part of its effort to advance the use of emerging technologies.]
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