Blog
The End-of-Phase 2 Meeting – Potential Drawbacks of Missing the Mark on this Critical Milestone
This blog, written by Eric Hardter, Director of Regulatory Affairs at Boyds, explores why the End-of-Phase 2 meeting is a critical milestone in drug development.
FDA Flexible CMC Requirements for Cell and Gene Therapies: What Sponsors Need to Know
In this blog, Moira Frances explores the FDA’s formalization of a flexible CMC framework for cell and gene therapies, examining what has changed and how sponsors can apply this approach to de-risk development and support successful BLA submissions.
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.