FDA Issues Final Guidance on "Emerging" Drug Manufacturing Technologies
The FDA has issued final guidance for biopharmas seeking to incorporate what the agency deems “promising emerging and novel technologies” in their drug manufacturing processes.The final guidance, titled “Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization,” offers recommendations to companies that are interested in participating in the FDA’sEmerging Technology Program.Through the program, biopharmas begin and maintain a di
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