Blog
8 Key Takeaways from the FDA’s Workshop on Advancing Pediatric Cell and Gene Therapy Clinical Trials
Our eight key takeaways from the FDA’s workshop on advancing pediatric cell and gene therapy clinical trials.
How Gene Therapy Could Transform Osteoarthritis Treatment
Exploring how gene therapy is transforming osteoarthritis treatment at a recent webinar hosted by the International Cartilage Regeneration and Joint Preservation Society
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.