Regenicin, Inc. Completes Successful Pre-IND Meeting
with Food and Drug Administration (FDA) for its
New Autologous Cultured Skin Substitute, NovaDerm®
(Little Falls, NJ) – November 1, 2016 - Regenicin, Inc. (OTC Bulletin Board: RGIN), a biotechnology company 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 completed the Pre-IND (Investigational New Drug) 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 cell therapy manufacturing facility by harvesting a small, stamp-size skin biopsy.
A Pre-IND meeting provides an opportunity for open communication between a sponsor and FDA/CBER/OCTGT to discuss planned IND content and to obtain advice from these centers. The FDA addressed the Company’s questions and provided guidance on the NovaDerm® development pathway moving forward.
“We are very pleased with the outcome of the pre IND meeting,” said Randall McCoy, CEO of Regenicin. “Our agreement with the FDA on the pathway to move forward has been clarified and confirmed. We will finalize our IND submission and continue to prepare for clinical trials.”
http://regenicin.com/Investor-Relations/relea...r1101.html
with Food and Drug Administration (FDA) for its
New Autologous Cultured Skin Substitute, NovaDerm®
(Little Falls, NJ) – November 1, 2016 - Regenicin, Inc. (OTC Bulletin Board: RGIN), a biotechnology company 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 completed the Pre-IND (Investigational New Drug) 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 cell therapy manufacturing facility by harvesting a small, stamp-size skin biopsy.
A Pre-IND meeting provides an opportunity for open communication between a sponsor and FDA/CBER/OCTGT to discuss planned IND content and to obtain advice from these centers. The FDA addressed the Company’s questions and provided guidance on the NovaDerm® development pathway moving forward.
“We are very pleased with the outcome of the pre IND meeting,” said Randall McCoy, CEO of Regenicin. “Our agreement with the FDA on the pathway to move forward has been clarified and confirmed. We will finalize our IND submission and continue to prepare for clinical trials.”
http://regenicin.com/Investor-Relations/relea...r1101.html
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