FDA unveils new pharma manufacturing program as part of draft guidance

As part of a draft guidance issued almost two weeks ago, the FDA is asking pharma companies to take part in a program that will review new, cutting-edge pharmaceutical manufacturing technology. The regulatory agency said the program is for companies submitting investigational drug applications, original or supplemental new drug applications, abbreviated new drug applications or biologic license applications. The FDA said it intends to work with companies on a case-by-case basis so that the agency can develop future guidance and standards for emerging manufacturing technology. Companies participating in the program would provide one or more elements that would be subject to quality assessment that the agency has not had any or very little experience with, and "where the technology has the potential to modernize the pharmaceutical manufacturing body of knowledge to support more robust, predictable or cost-effective processes." Article

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