Blog

The European Commission, participating Member States and the European Medicines Agency (EMA) have announced the launch of the first phase of the COMBINE Project 1 pilot.

The European Commission has announced plans to set up a dedicated expert panel in the field of orphan and paediatric medical devices.

In April 2025, the US Food and Drug Administration (FDA) announced plans to phase out animal testing requirements for development of monoclonal antibodies (mAbs) and other drugs, and instead rely on human-relevant methods, such as in silico and in vitro human-based systems, for safety testing.

In this expert guide, Chris Moore, Senior Clinical Project Manager at Boyds, shares 10 essential considerations for U.S. biotechs looking to set up successful clinical trials in Europe under the new Clinical Trials Regulation (CTR) and CTIS system.

The European Union (EU) has one of the most advanced regulatory frameworks for healthcare innovation in the world. However, this complexity can pose significant challenges, particularly when clinical studies involve more than one category of health technology.

In this blog, Dr Katherine Bowen, Chief Regulatory Affairs Officer at Boyds, provides her top tips for obtaining EU marketing authorization through the centralised procedure.

In January 2025, the Food and Drug Administration (FDA) issued long-awaited draft guidance on the use of artificial intelligence (AI) in regulatory decision-making for drugs and biological products. In this blog, the Boyds Regulatory Affairs team outlines the new guidance and its aims.

Recognizing Rare Disease Day and Its Impact. February 28, 2025, marks Rare Disease Day – a global initiative dedicated to raising awareness and driving change for the 300 million people worldwide living with a rare disease, along with their families and carers.