source
- European trade group urges authorities to grant notified bodies access to Eudamed for risk-based oversightA trade association representing notified bodies has formally asked EU regulators to allow them to access the Eudamed database. The group says that such access would enable them to apply the risk-…
- FDA releases draft PDUFA VIII commitment letter outlining goals and enhancements for 2028-2032The FDA on Thursday issued a proposed commitment letter for the upcoming PDUFA VIII cycle, which will cover fiscal years 2028 through 2032. The letter sets out the agency's performance targets for…