The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.
News|Videos|October 13, 2026
Manufacturing Intelligence: What FDA's Real-World Use Case Database Means for CMC
Author(s)Richard Jaenisch, Christopher Cole
Richard Jaenisch explains what FDA's real-world use case database means for CMC and quality teams navigating NAMs.
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The FDA's expanding embrace of new approach methodologies (NAMs) is forcing pharmaceutical manufacturing and quality teams to rethink how preclinical and CMC data will be generated, validated, and used. Richard Jaenisch, speaking with PharmTech associate editorial director Christopher Cole, lays out both the promise and the unresolved questions that come with it.
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