RealFeedApp FDA issues new rules for cell therapy potency testing
The agency issued final guidance requiring manufacturers to implement a potency assurance strategy across the entire lifecycle of cell and gene therapy products to ensure batch consistency before patient delivery.
- Field
- gene therapy
- What they did
- The FDA issued new regulations for cell and gene therapy manufacturers, requiring them to implement a potency assurance strategy at every stage of development.
- Why it matters
- This is necessary to ensure that every batch of the therapy meets the required potency standards before it reaches a patient.
#cell therapy#gene therapy#fda#potency assurance#clinical trial
