FDA
FDA preserves ANDA references for discontinued products
FDA determined that DIBENZYLINE 10 mg capsules and other listed drug products were not withdrawn for safety or effectiveness reasons. The agency may continue approving qualifying ANDAs that reference them.
Read the official sourceMHRA
MHRA reports email disruption
MHRA said it was experiencing problems sending and receiving emails during a Microsoft outage.
Read the official sourceMHRA
MHRA publishes quarterly performance reporting
MHRA released quarterly reports providing performance information and projections across 2026 and 2027.
Read the official sourceFDA
FDA seeks comments on veterinary feed directive information collection
FDA opened a 60 day comment opportunity covering reporting, recordkeeping, and third party disclosure burdens under veterinary feed directive regulations.
Read the official sourceFDA
FDA seeks comments on importer program information collection
FDA opened a 60 day comment opportunity on information collection associated with its Voluntary Qualified Importer Program.
Read the official sourceWhy this matters
The FDA determination clarifies that qualifying generic applications may continue to reference the listed products. Regulatory teams should also account for MHRA communication disruption, review its performance reporting, and note FDA opportunities to comment on administrative burdens.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.