FDA
FDA opens public input on BsUFA reauthorization
FDA will hold a hybrid public meeting and accept comments on proposed recommendations for the Biosimilar User Fee Act for fiscal years 2028 through 2032. The current authority expires in September 2027.
Read the official sourceFDA
FDA issues draft guidance for robotically assisted surgical devices
The draft provides recommendations for premarket submissions for robotically assisted surgical devices. It is not final or ready for implementation.
Read the official sourceFDA
FDA schedules advisory committee review of atropine ophthalmic solution
FDA announced a public Dermatologic and Ophthalmic Drugs Advisory Committee meeting concerning NDA 219694 for atropine sulfate ophthalmic solution, 0.01%, and established a public comment docket.
Read the official sourceEMA
EMA opens consultation on sickle cell disease clinical requirements
EMA published a draft guideline covering clinical requirements for medicines intended to treat sickle cell disease. Consultation is open.
Read the official sourceEMA
EMA opens consultation on thalassaemia clinical requirements
EMA published a draft guideline covering clinical requirements for medicines intended to treat thalassaemia. Consultation is open.
Read the official sourceEMA
EMA adopts revised CHMP GCP inspection coordination procedure
EMA adopted Revision 1 of its procedure for coordinating good clinical practice inspections requested by the CHMP.
Read the official sourceWhy this matters
These updates create immediate opportunities to assess and comment on emerging expectations for biosimilar review funding, robotic surgical device submissions, and clinical development in two hematologic diseases. EMA’s adopted inspection procedure also provides a current reference for how CHMP requested GCP inspections are coordinated.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.