FDA
FDA finalizes two dental device 510(k) guidances
The guidances provide recommendations for device descriptions, performance testing, and labeling for dental composite resin devices and dental curing lights. They supersede guidance from 2005 and 2006.
Read the official sourceFDA
FDA issues final VICH guidance on genotoxicity testing
Final GFI #116, VICH GL23(R2), addresses internationally harmonized genotoxicity testing of veterinary drug residues in human food.
Read the official sourceFDA
FDA issues final VICH guidance on reproduction testing
Final GFI #115, VICH GL22(R), covers reproduction testing for effects associated with long term, low dose exposure to veterinary drug residues in food.
Read the official sourceEMA
EMA updates centralized procedure advice
EMA published updated pre-authorisation procedural advice for users of the centralized procedure under reference EMA/24037/2019.
Read the official sourceMHRA
MHRA calls for filters during parenteral nutrition administration
The safety alert states that filters should be used in all care settings. Administration without a filter has been associated with adverse incidents, including a fatal embolism.
Read the official sourceFDA
FDA clears a pathway for Phenaphen with Codeine ANDAs
FDA determined that Phenaphen with Codeine No. 3 and No. 4 capsules were not withdrawn for safety or effectiveness reasons. ANDAs may be approved if all other requirements are met.
Read the official sourceWhy this matters
Regulatory teams should work from the current FDA and EMA guidance when preparing submissions, while the MHRA alert warrants attention to administration instructions and safety communications for parenteral nutrition. FDA’s withdrawal determination also preserves a route for qualifying generic applications.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.