Blog
The FDA’s Manufacturing Flexibilities for Cell and Gene Therapies Guidance – Another Cog in the Nebulous Machine
Boyds Director of Regulatory Affairs, Dr Eric Hardter, dives deep into the FDA’s manufacturing flexibilities for cell and gene therapies guidance.
Fast Track, Breakthrough Therapy and RMAT: Choosing the Right FDA Expedited Pathway
Discover how FDA expedited pathways, including Fast Track, Breakthrough Therapy and RMAT, can support faster and more efficient product development.
Advancing CMC in Accelerated Programs: Insights on the FDA’s CDRP Program
The FDA launched the CMC Development and Readiness Pilot (CDRP) Program in 2023 as part of PDUFA VII commitments.
EU PRIME Scheme for priority medicines
PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines targeting unmet medical needs
MHRA-UK – The Innovative Licensing and Access Pathway (ILAP)
The ILAP is a program designed to facilitate and accelerate the development of innovative medicines and drug-device combinations.
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.