FDA Launches Pilot Program for Novel Excipients

A new program at the FDA’s Center for Drug Evaluation and Research (CDER) aims to develop novel excipients with the potential to lead to novel drug development.

Over the next two years, the Novel Excipient Review Pilot Program will accept four agents that haven’t been used in any FDA-approved drug and which aren’t already being used in food.

The program defines excipient as any product that is not intended to exert therapeutic effects at the intended dosage, although it may improve product delivery. Examples include fillers, extenders, diluents, wetting agents, solvents, emulsifiers, preservatives, flavors, absorption enhancers, sustained-release matrices and coloring agents.

The pilot program “will foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients,” CDER said.