Blog

The field of clinical trials within the European Union (EU) has undergone a significant transformation in recent years driven by implementation of the new Clinical Trials Regulation (EU No 536/2014) (CTR) aimed at harmonisation of the rules across the EU for conducting clinical trials, enhancing patient safety, data transparency and overall trial efficiency.

In this three-part blog series, Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, provides advice and guidance to sponsors on conducting FDA meetings and discusses ways of ensuring a productive outcome.

National DNA Day focuses on the successful completion of the Human Genome Project back in 2003, as well as the discovery of DNA’s double helix in 1953.

In this blog, Katy Rudnick, Vice President and Head of US Regulatory Affairs at Boyds, explores the latest trends in US drug development and initiatives at the FDA and discusses their potential impact on drug development in 2024.

In this article, Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, discusses the investigational phase of the rare disease drug development process with a focus on US regulatory requirements.

In this blog, Dr Eric Hardter, Associate Director of Regulatory Affairs, discusses the critical importance of proper planning and early engagement with FDA for Investigational New Drug (IND) applications.

In this blog, Boyds’ Dr Katherine Bowen, Senior Director of Regulatory Affairs, and Dr Julie Warner, Vice President of Regulatory Affairs, explore the ever-evolving world of oncology drug development and the regulatory landscape in the US and EU.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published the “MHRA Roadmap towards the future regulatory framework for medical devices”. With the of release of this document on the 9th January 2024, the Agency has provided an update on the intended timelines to implement the future core regulations via a series of new Statutory Instruments.