(Little Falls, NJ) – October 12, 2016 - Regenicin, Inc. (OTC Bulletin Board: RGIN), a biotechnology company specializing in the development and commercialization of regenerative cell therapies to restore the health of damaged tissues and organs, today announced that they have scheduled a Pre-IND Meeting via teleconference with members of the FDA Office of Cellular, Tissue, and Gene Therapies (OCTGT) in the Center for Biologics Evaluation and Research (CBER) on October 27th, 2016 regarding its product NovaDerm®.
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.
“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,” said Randall McCoy, Chief Executive Officer of Regenicin.
Regenicin, Inc. (OTC Bulletin Board: RGIN), is a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs. Regenicin, which was founded in 2010, has assembled a world-class management team with a proven track record for developing and bringing innovative medical devices and biotechnology products to market. The company is publicly traded with headquarters in New Jersey. For more information on Regenicin, Inc., as well as its technologies and products, please visit the company website at www.regenicin.com.
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