FDA
FDA announces FY 2027 priority review voucher fee rate
FDA established the FY 2027 fee rate for eligible human drug or biological product applications using certain priority review vouchers and outlined payment procedures.
Read the official sourceEMA
EMA adopts revised pharmacovigilance inspection guidance
EMA adopted revision 2 of GVP Module III on pharmacovigilance inspections.
Read the official sourceFDA
FDA classifies vascular access fistula support as class II
FDA classified extravascular support for an arteriovenous fistula for vascular access into class II with special controls.
Read the official sourceFDA
FDA classifies inflammatory bowel disease test system
FDA classified the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease into class II with special controls.
Read the official sourceMHRA
UK commission recommends a future framework for healthcare AI
The National Commission into the Regulation of AI in Healthcare published recommendations intended to advise government on a future regulatory framework.
Read the official sourceMHRA
MHRA publishes August 2026 advertising investigation decisions
MHRA released decisions concerning medicine advertisements reported as potentially breaching advertising legislation.
Read the official sourceWhy this matters
Regulatory teams have new operational information for voucher based submissions and an adopted European inspection guideline to assess. FDA’s device orders codify special controls for distinct technologies, while the UK updates provide current signals on medicines advertising and the possible direction of healthcare AI oversight.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.