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- FDA’s new CBER and CDER heads back adaptive framework for rare disease therapiesNewly appointed permanent directors of FDA’s CBER and CDER, Karim Mikhail and Michael Davis, indicated they will continue the agency’s push for an adaptive regulatory framework aimed at rare diseas…
- Regulators call for unified AI guidelines in drug development at RAPS Convergence 2026Regulators and industry experts gathered at RAPS Convergence 2026 in Charlotte, NC to discuss the growing role of artificial intelligence in drug development. The panel highlighted that differing…