FDA
FDA finds sulfadiazine tablets were not withdrawn for safety or effectiveness reasons
FDA determined that SULFADIAZINE 500 mg tablets were not withdrawn for safety or effectiveness reasons. The agency may approve ANDAs if all other legal and regulatory requirements are met.
Read the official sourceFDA
FDA withdraws approval of the Mysoline suspension NDA
FDA is withdrawing approval of NDA 010401 for MYSOLINE (primidone) suspension, 250 mg/5 mL. Application holder FHTA LLC agreed to the withdrawal and waived a hearing.
Read the official sourceFDA
FDA opens comment on an information collection
FDA announced a 60 day public comment opportunity concerning a proposed information collection. The notice solicits comments on requirements for tracking medical devices.
Read the official sourceFDA
FDA sends additive petition collection to OMB
FDA submitted a proposed information collection covering food and color additive petitions, related master files and electronic Form 3503 submissions to OMB for review and clearance.
Read the official sourceMHRA
MHRA updates guidance on COVID-19 test approval
MHRA published guidance explaining how manufacturers or distributors can apply for approval to place COVID-19 test devices on the UK market.
Read the official sourceMHRA
MHRA updates exceptional use authorisation information
MHRA published its list of manufacturers and medical devices granted exemptions, including exemptions that expired or were cancelled.
Read the official sourceWhy this matters
The FDA actions clarify the regulatory status of two established drugs and identify active information collection processes. The MHRA updates give device manufacturers current reference points for UK COVID-19 test approvals and exceptional use authorisations.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.