FDA
FDA finalizes emergency pathogen IVD validation guidance
The guidance provides general validation recommendations for certain IVDs during an applicable declared public health emergency. It covers data and information submitted through pre EUA interactions, EUA requests, or applicable enforcement discretion policies.
Read the official sourceFDA
FDA removes one authorized use of methylene chloride
FDA removed methylene chloride as a diluent in color additive mixtures used in inks for marking fruit and vegetables under the Delaney Clause. It denied requests concerning specified extraction solvent uses because residues would be impurities not subject to that clause.
Read the official sourceFDA
FDA removes abandoned extraction solvent uses
FDA removed authorized uses of methylene chloride, trichloroethylene, and ethylene dichloride as extraction solvents for annatto extract, paprika oleoresin, and turmeric oleoresin based on permanent abandonment.
Read the official sourceMHRA
MHRA highlights AI Airlock for medical devices
MHRA described AI Airlock as a collaborative regulatory sandbox focused on identifying and addressing challenges faced by AI enabled medical devices.
Read the official sourceMHRA
MHRA updates terminated and cancelled licence information
MHRA published information on UK companies whose licences to manufacture or wholesale medicines have been terminated and cancelled.
Read the official sourceWhy this matters
Regulatory teams now have final FDA recommendations for emergency IVD validation and revised legal boundaries for several color additive uses. The MHRA updates also provide useful visibility into its approach to AI enabled devices and the current status of UK manufacturing and wholesale licences.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.