EMA offers Information session on breakthrough medical devices (BtX)
At end of 2025, the EU Medical Device Coordination Group (MDCG) published a guidance introducing the Breakthrough Devices framework (MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746 ).
The End-of-Phase 2 Meeting – Potential Drawbacks of Missing the Mark on this Critical Milestone
This blog, written by Eric Hardter, Director of Regulatory Affairs at Boyds, explores why the End-of-Phase 2 meeting is a critical milestone in drug development.
Achieving FDA and EMA alignment for a first-in-class gene therapy program
A gene therapy company was working with Boyds on the regulatory strategy for their first in-class treatment for a rare disease that included a complex, novel delivery device and sought Boyds’ advice on how best to gain global regulatory feedback and alignment on their planned pivotal trial.
Getting a rare disease phase 3 program back on track through global regulatory alignment
A US-based small biotech company approached Boyds as they were about to commence their Phase 3, single pivotal trial in a rare disease for which they had orphan designation.