FDA
FDA removes two active ingredients from the OTC sunscreen monograph
A final administrative order removes PABA and trolamine salicylate as sunscreen active ingredients from OTC Monograph M020. FDA states that sunscreen products containing either ingredient are not generally recognized as safe and effective.
Read the official sourceFDA
FDA classifies cardiovascular machine learning notification software
FDA classified cardiovascular machine learning based notification software as class II with special controls, which will become part of the codified classification language.
Read the official sourceFDA
FDA seeks comments on medical device tracking information collection
FDA opened a 60 day public comment opportunity on information collection requirements for tracking medical devices under the Paperwork Reduction Act.
Read the official sourceEMA
EMA opens consultation on revised migraine and cluster headache guideline
EMA published Revision 2 of its draft guideline on clinical investigation of medicinal products for migraine and cluster headache, with consultation open.
Read the official sourceMHRA
Independent commission outlines blueprint for safe healthcare AI adoption
Recommendations based on public engagement describe how the NHS could accelerate access to AI advances while applying proportionate safeguards for patient safety and trust.
Read the official sourceWhy this matters
Regulatory teams should note the immediate change to the US OTC sunscreen monograph and the new class II framework for cardiovascular machine learning notification software. The FDA device tracking notice and EMA consultation also create formal opportunities to provide input, while the UK recommendations add to the evolving policy discussion around healthcare AI.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.