Amicrobe Holds Pre-IND Face-to-Face Meeting with the FDA on Amicidin-α Surgical Gel
SILVER SPRING, MD - OCTOBER 18, 2018 - Amicrobe, Inc. has successfully completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for Amicidin-α Surgical Gel. The meeting was conducted face-to-face at the FDA’s facilities, and was attended by 14 senior personnel from the the Division of Anti-Infective Products in the Center for Drug Evaluation and Research (CDER).
Amicrobe requested and received a pre-IND meeting with the agency early in its pre-clinical development program of its innovative, non-traditional product, Amicidin-α Surgical Gel. The face-to-face meeting provided valuable feedback for the development program, from manufacturing to nonclinical GLP toxicology studies to clinical development strategy.
Dr. Michael Bevilacqua, CEO and CSO of Amicrobe, stated “Amicrobe strives to build strong relations with the FDA, and this Pre-IND meeting on Amicidin-α Surgical Gel was an excellent step.”