FDA Finalizes Guidance on Checking the Potency of Cell and Gene Therapies
The U.S. Food and Drug Administration has issued its final guidance on how makers of cell and gene therapies should confirm that their products work as intended. The guidance covers the full life of a product, from early testing to licensed sale. Potency here means the strength of a product's intended biological effect.
This summary was generated by AI; the official source prevails.
What does it mean?
Companies that make cell and gene treatments now have a final FDA rulebook-style guide on proving their products have the right strength. It applies both to treatments still in testing and to approved products that are released in batches. Public comments can still be filed through the docket.
Who is affected?
Companies developing or manufacturing cellular and gene therapy products.
What changes?
Earlier, FDA had only a draft guidance from December 28, 2023; the document is now final.