Demystifying regulatory designations in drug development
In recent decades, we’ve seen a significant increase in the number of regulatory designation schemes launched by regulators to incentivise development in specific areas underserved by current therapies.
How to become investor ready: a guide for early-stage biotechs
For many early-stage and start-up biotech companies, a key consideration is how to prepare to be investor ready, to raise the funding required to progress product development programs.
Part 3: Navigating an FDA meeting – best practices for maximizing your time and effort
In this three-part blog series, Dr Eric Hardter, Associate Director of Regulatory Affairs at Boyds, provides advice and guidance for sponsors on conducting FDA meetings and discusses ways of ensuring a productive outcome.
Part 2: Navigating an FDA meeting – best practices for maximizing your time and effort
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.
A reflection on the EU Clinical Trials Regulation and future prospects
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.
Part 1: Navigating an FDA meeting – best practices for maximizing your time and effort
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: 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.
