FDA
FDA publishes draft strategy for interchangeable biosimilars
The document summarizes FDA's 2025 public workshop and describes future directions for supporting interchangeable biosimilar products. It was issued for public comment under a BsUFA III commitment.
Read the official sourceFDA
FDA outlines electronic submission resources for certain PMAs
Draft guidance introduces current resources and content supporting electronic submission of certain PMAs and supplements. It is not final or ready for implementation.
Read the official sourceFDA
FDA issues harmonized draft guidance for veterinary monoclonal antibodies
Draft GFI #298, developed through VICH, addresses target animal safety studies for veterinary monoclonal antibody products under laboratory and field conditions.
Read the official sourceMHRA
MHRA opens consultation on 2026 statutory fees
The consultation presents proposals for ongoing cost recovery and funding of higher value services.
Read the official sourceMHRA
MHRA reports barcode error affecting clobazam batches
A Class 4 medicines defect notification identifies a linear barcode error affecting some batches of two strengths of Clobazam Martindale Pharma oral suspension.
Read the official sourceMHRA
MHRA identifies radiofrequency risks in wireless CTG systems
Following a review, MHRA identified signal crossover, erroneous traces, and signal dropouts as patient safety risks associated with wireless cardiotocography systems using radiofrequency telemetry.
Read the official sourceWhy this matters
Regulatory teams have new draft materials to assess across biosimilars, medical devices, and veterinary products, plus an MHRA consultation that could shape statutory fees. The UK safety notices also reinforce the need to monitor labeling, identification, and device signal issues after products reach the market.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.