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# Abeona Pz-Cel BLA Moving Forward
- URL: https://www.fdaweb.com/abeona-pz-cel-bla-moving-forward/
- Published: 2024-02-01T12:00:00.000Z
- Updated: 2026-09-14T14:21:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156276

As part of its review of an Abeona Therapeutics BLA for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa, FDA has completed a bioresearch monitoring inspection of Abeona and the BLA mid-cycle review meeting. A company [statement](https://investors.abeonatherapeutics.com/press-releases/detail/271/abeona-therapeutics-announces-progress-update-on-pz-cel?ref=fdaweb.com) says the 1/22-1/24 inspection did not result in any observations or issuance of a form FDA-483.

At the mid-cycle review meeting, FDA reaffirmed that it does not intend to convene an advisory committee to consider the BLA and said it does not anticipate requiring a risk evaluation and mitigation strategy for it, Abeona says. The agency reconfirmed its expected PDUFA action date of 5/25.