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- Experts call for Congress to create a dedicated regulatory framework for AI models used in academic medical centersOn Oct. 15, 2026, several health policy experts voiced support for a new regulatory approach specifically aimed at clinical artificial‑intelligence models that are developed and deployed in academi…
- FDA advises early engagement and error prevention for BLA submissions, says CBER expertA CBER specialist shared practical guidance for companies preparing biologics license applications. The expert stressed that early interaction with the FDA’s Office of Therapeutic Products can str…