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Microbiome Therapeutics Innovation Group issued the following announcement on June 17.
On June 13, 2019, the U.S. Food and Drug Administration (FDA) issued a safety alert regarding the use of fecal microbiota for transplantation, or FMT:
Our MTIG members are committed to the development of therapeutic microbiota-based products that are safe and effective. All of our member companies are developing investigational products in compliance with the FDA guidelines for Investigational New Drugs, including donor testing and/or quality control requirements. We are working actively with the FDA to develop guidelines for the application of pharmaceutical development criteria related to microbiota-based therapeutics and for the evaluation of safety parameters related to microbiota-based therapeutic products. MTIG fully supports the continued vigilance of the FDA in regulating this field to better assure that patients have access to safe and effective treatments.
About the Microbiome Therapeutics Innovation Group
The Microbiome Therapeutics Innovation Group (MTIG) is a coalition of companies leading the research and development of FDA-approved microbiome therapeutics and microbiome-based products to address unmet medical needs, improve clinical outcomes, and reduce health care costs. The human microbiome is one of the new frontiers of medical innovation that has the potential to benefit patients suffering from numerous diseases afflicting millions of patients and consuming billions of dollars of healthcare resources. MTIG is committed to working with stakeholders who share in our mission and seek tangible policy and regulatory solutions in the emerging microbiome arena. Through a collective voice, the MTIG membership works together to enhance the regulatory, investment, and commercial environment to accelerate microbiome therapeutic product development and enable the field to reach its potential to benefit patients.
Today, the MTIG is comprised of three companies: Rebiotix, Inc., Seres Therapeutics, and Vedanta Biosciences.
All pharmaceutical and biotechnology companies pursuing regulatory approvals for microbiome therapeutics and microbiome-based products are eligible for consideration of membership in MTIG. If you are interested in learning more about becoming a member, please contact us here.
Original source can be found here.
