Indianapolis-based Toralgen Inc. says it has been accepted into the U.S. Food and Drug Administration’s Emerging Technology Program. The biotechnology company is developing ways to improve drug delivery tools to administer microscopic-sized doses of medication.
The FDA created the program to help promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.
The company says it can now meet with members of the Emerging Technology Team to discuss potential technical and regulatory roadblocks of the novel technology.
Toralgen says this is an important step along the regulatory approval process.
“We are encouraged that our technology was well received by the Emerging Technology Team,” said Gerald Rea, Toralgen Chief Executive Officer. “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 says its poly-bile acid nanoparticle platform has the potential to improve outcomes through optimized drug delivery.