Mohammad Heidaran, of the Office of Cellular, Tissue and Gene Therapies, CBER at the FDA, presented at the Stem Cells & Regenerative Medicine Congress in 2013. Enclosed are his presentation slides from the event, where he addresses clarifying aspects like potency assays, purity and identity assessment.
You can now view the recording of his presentation alongside these slides, so that you can both hear his presentation and view the slides he's referring to up close. After all, we wouldn't want you to miss anything, right?
Download the presentation to hear what the FDA had to say about:
- Jurisdictional updates
- OCTGT Guidances
- PDUFA V
- Process validation
- Sterility testing
- Breakthrough therapy
- Cost recovery
- Manufacturing control and consistency
- Current good manufacturing practices (CGMP)