Blog
Part 3: Ensuring a Productive FDA Meeting and Clear Next Steps
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: Developing a Strong FDA Meeting Package and Regulatory Strategy
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.
Part 1: Laying the Foundations for a Successful FDA Meeting
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.
Nitrosamine Impurities: A Persistent Regulatory Challenge in Drug Development
Explore how FDA and EMA guidance is shaping nitrosamine risk assessments and why robust strategies are essential to avoid major objections in regulatory submissions.
Rare Disease Day 2026: Accelerating Regulatory Innovation for Rare and Ultra-Rare Diseases
Since its creation in 2008, Rare Disease Day is observed every year on February 28th (or 29 February in leap years – the rarest day of the year). The day provides an opportunity to advocate for rare diseases as a human rights priority at local, national, and international levels, promoting a more inclusive society.
Shifts in FDA Thinking: What a Single‑Trial Pathway Could Mean for Drug Development
The recent NEJM commentary from Drs. Marty Makary and Vinay Prasad hints at a potential shift in FDA expectations – stating that a single well‑designed pivotal trials is now the default position for US approval ending the widely held doctrine that two pivotal trials are generally required.
FAST-EU: A New Era for Multinational Clinical Trials in Europe
In this blog, Shalini Gupta explores the launch of FAST-EU (Facilitating and Accelerating Strategic Clinical Trials in the EU) and what it means for sponsors navigating multinational clinical trials in Europe.
Bringing Clarity to ATMP Analytics: The Value of Best Practice Guidance
Moira Francois explores how the British Pharmacopoeia’s (BP) ATMP Best Practice Guidance is bringing much-needed clarity and consistency to ATMP analytics. By supporting developers in building robust, scientifically sound analytical strategies, this guidance plays a key role in safeguarding product quality and, ultimately, patient safety.