Blog
National DNA Day: Gene Therapy – The future has arrived.
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.
The latest trends in US drug development
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.
Navigating the complexities of rare disease drug development
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.
The FDA Pre-IND Meeting – A Best Practice for Mitigating Early Regulatory Risk
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.
Navigating the regulatory landscape in oncology drug development
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.
MHRA announces new pathway for device regulations
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.
The importance of diversity in clinical trials
In this article, Dr Harriet Gray-Stephens, Pharmaceutical Physician in the Clinical and Medical Affairs team at Boyds, discusses the importance of diversity in clinical trials and the steps that are being taken to improve the quality of data derived from clinical research.
A guide to plain language summaries (PLS)
In this blog, Naomi Clout, Senior Regulatory and Medical Writer at Boyds, discusses the importance of Plain Language Summaries as an effective scientific communication tool that can be easily comprehended by people who aren’t experts in the field and the steps involved in creating a PLS.
