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- FDA urges biosimilar sponsors to use alternative efficacy studies while AI reshapes regulatory workAI is becoming common in regulatory work. Experts say it will not replace regulatory professionals but will help them work more efficiently and free up time for human interaction. They stress that…
- Congress faces Dec. 11 deadline to fund government, shaping lame-duck session and health-care agendaDemocrats have taken control of both the House and Senate, but Republicans will remain in power until the new Congress convenes in January. Lawmakers must pass a funding bill by Dec. 11 to avoid a…