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news.Biotechnology company Regenicin will have a Pre-IND Meeting via teleconference regarding its product NovaDerm with members of the FDA Office of Cellular, Tissue, and Gene Therapies (OCTGT) in the Center for Biologics Evaluation and Research (CBER) on 27 October.
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NovaDerm, which recently received its orphan-drug designation from the FDA, is a regenerative cell therapy that has the potential to re-grow a patient’s own skin in a laboratory by harvesting a small, stamp-size skin biopsy.
An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
A Pre-IND meeting provides an opportunity for open communication between a sponsor and the FDA, CBER, OCTGT to discuss planned IND content and to obtain advice from these centers.
Prior to this meeting, Regenicin submitted an information package describing the proposed content and format of the regulatory, Chemistry, Manufacturing, Controls (CMC), non-clinical product development work as well as a proposed clinical trial synopsis.
This meeting will afford Regenicin the opportunity to gain further understanding of the FDA’s expectations regarding these key sections of the IND.
Regenicin CEO Randall McCoy said: “We are pleased to have begun discussions with the Agency regarding our proposed IND submission for NovaDerm, and are very excited to have reached another milestone for Regenicin.”