FDA shared on LinkedIn:
“FDA released a draft guidance with recommendations for developing assays to assess potency as part of a potency assurance strategy for active immunotherapy products.
The guidance covers:
- Product-specific, risk-based approaches to potency assay developmen
- Use of physicochemical methods to assess potency
- Assay examples applicable to various types of ACTIMPs
Review the guidance and submit comments here: Potency Assessment of Active Immunotherapy Products.”
Other articles about FDA and immunotherapy on OncoDaily.