FDA
FDA announces year five of CMC readiness pilot
The agency outlined eligibility criteria and the process for requesting participation in a pilot supporting CMC readiness for CBER and CDER products with accelerated clinical development timelines.
Read the official sourceFDA
Orphan drug information collection moves to OMB review
FDA submitted a proposed orphan drug information collection to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act.
Read the official sourceEMA
EMA opens consultation on systemic sclerosis clinical investigations
EMA published a draft reflection paper on the clinical investigation of medicinal products for treating systemic sclerosis, with consultation open.
Read the official sourceEMA
EMA adopts veterinary post approval change management Q&A
EMA adopted questions and answers on post approval change management protocols for veterinary medicinal products.
Read the official sourceEMA
Veterinary signal management revision enters consultation
EMA opened consultation on Revision 1 of its veterinary good pharmacovigilance practices module for signal management.
Read the official sourceMHRA
MHRA updates 2026 marketing authorisations record
MHRA published its record of marketing authorisations granted in 2026.
Read the official sourceWhy this matters
The FDA pilot provides a defined route for eligible sponsors to seek increased agency communication on CMC readiness during accelerated development. In Europe, the open consultations give stakeholders an opportunity to examine emerging expectations, while the adopted veterinary Q&A provides a current reference for post approval change planning.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.