FDA
FDA finalizes cellular and gene therapy potency guidance
FDA finalized recommendations for assuring CGT product potency across the lifecycle. The guidance describes progressive implementation during development, considerations for rapid clinical development, and requirements for licensed products, including lot release testing.
Read the official sourceFDA
FDA updates hepatitis B testing recommendations for blood collections
FDA finalized recommendations for hepatitis B virus testing of Whole Blood and blood components, including Source Plasma. The guidance replaces or supersedes several earlier FDA documents and recommendations.
Read the official sourceMHRA
UK publishes Inclusion and Diversity Plan pilot findings
The Health Research Authority published findings from its pilot involving researchers and sponsors developing and submitting Inclusion and Diversity Plans for clinical trials and clinical investigations.
Read the official sourceWhy this matters
The two final FDA guidances give regulatory teams current recommendations for CGT potency strategies and hepatitis B testing, while replacing earlier drafts or recommendations. The UK pilot findings provide a new reference point for sponsors considering how inclusion and diversity planning is developed and submitted in clinical research.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.