Toralgen accepted into FDAs Emerging Technology Program
INDIANAPOLIS, IN., Nov 30, 2020 — Toralgen, Inc., an Indiana-based biotechnology company is pleased to announce that it was accepted into the FDA’s Emerging Technology Program. Toralgen is a preclinical stage company focused on developing a proprietary bile acid platform that has the potential to significantly improve drug delivery.
The Emerging Technology Program was created by FDA to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing. Through the program, industry representatives can meet with Emerging Technology Team (ETT) members to discuss, identify, and resolve potential technical and regulatory issues regarding the development and implementation of a novel technology prior to filing a regulatory submission. We view this as the beginning of a productive partnership with regulators to ensure safe development and implementation of this novel drug delivery technology.
“We are encouraged that our technology was well received by the Emerging Technology Team,” said Gerald Rea, CEO “We appreciate the opportunity to gain valuable guidance as we develop a drug delivery platform that has so many potential applications across a wide variety of therapeutic areas.”
Toralgen is a preclinical stage biopharmaceutical company focused on the development and commercialization of human therapeutics. Its poly-bile acid nanoparticle platform eliminates many of the innate challenges of biologics and has the potential to improve outcomes through optimized drug delivery. The company is currently studying treatments for Diabetes and AutoImmune disorders. For more information or to contact us about possible collaborations, please visit www.toralgen.com.