FDA
HHS opens docket on regulation of deceased donor islet therapies
HHS is requesting data and comments on how deceased donor islet cells and cell products for Type 1 diabetes should be regulated, including whether unmodified cells could be defined as organs.
Read the official sourceEMA
EMA adopts revised veterinary residues guideline
EMA adopted Revision 63 of its procedural guideline on substances considered outside the scope of Regulation (EC) No. 470/2009 for residues of veterinary medicines in foodstuffs of animal origin.
Read the official sourceMHRA
MHRA reports leaflet errors in some meropenem batches
B. Braun Melsungen AG notified MHRA of errors in the patient information leaflet included with some batches of Meropenem 1000 mg powder and solvent for infusion.
Read the official sourceMHRA
MHRA approves lurbinectedin for extensive stage small cell lung cancer
MHRA approved lurbinectedin for adults with extensive stage small cell lung cancer and said it will keep the medicine’s safety and effectiveness under close review.
Read the official sourceWhy this matters
The HHS docket offers a direct opportunity to inform a developing regulatory approach for deceased donor islet therapies. The European updates also reinforce the need to track adopted guidance, product information defects, and national authorization decisions across distinct regulatory frameworks.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.