Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicants

From Regulatory News:

Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval after submission compared to batch manufacturing products, according to results from a US Food and Drug Administration (FDA) audit published in the International Journal of Pharmaceuticals.

Authors from the FDA Center for Drug Evaluation and Research (CDER) said these manufacturers had a potential estimated increase in revenue due to the CM products having more time in the market because of quicker approval. Use of CM technology also did not appear to affect whether these products underwent manufacturing process changes or pre-approval inspections on FDA’s end, the agency said.

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