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- Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meetingThe FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal…
- Experts review five decades of regulatory evolution at RAPS Convergence 2026At the opening plenary of RAPS Convergence 2026 in Charlotte, NC, specialists in medical device and pharmaceutical regulatory affairs gathered to discuss the field’s trajectory. They reflected on…