Blog
FDA launches new program to advance neuroscience medical product development
In this blog, we explore the FDA’s new NAIN program, its aims to advance neuroscience medical product development, and its first priority: accelerating drug development for Alzheimer’s prevention and early intervention.
The EU SoHO Regulation: What Cell and Gene Therapy Manufacturers Need to Know
The EU’s new Regulation on Substances of Human Origin introduces important changes to the quality, safety and traceability requirements for human-derived materials. In this blog, Jan Ohotski and Moira Francois discuss what the regulation means for cell and gene therapy manufacturers, the key compliance requirements, and how to prepare ahead of its application in August 2027.
The Expedited Investigational New Drug (IND) Pilot Program – The FDA’s Personal Transfer of Regulatory Obligations?
On 15 September 2026, the US FDA announced the final design of their Expedited IND Pilot Program.
Q&A: What is a fractional Chief Medical Officer and when does a biotech need one?
In this Q&A, Dr Laurence Skillern, Chief Medical Officer at Boyds, explores what fractional CMO support involves and when it can add the most value.
MHRA position on UK licensing route for microbiome-based medicines
In this blog, Moira Francois explores the MHRA’s position on the UK licensing route for microbiome-based medicinal products (MBMPs), highlighting key regulatory, CMC, and GMO considerations for developers navigating this emerging therapeutic area.
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.