BIG NEWS for Innovation in Drug and Excipient Development!!! New FDA Novel Excipient Review Pilot Program
FDA launches a Novel Excipient Review Pilot Program to foster development of novel inactive ingredients (excipients) and address approval challenges!
Today, the U.S. Food and Drug Administration (FDA) introduced the Novel Excipient Review Pilot Program, a new pathway for manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. IPEC-Americas and the IQ Consortium provided proposals for this type of an independent novel excipient qualification program to FDA a few years ago and we are thrilled that FDA now plans to launch this Pilot Program to see how this concept works.
I have been actively involved in these proposals and discussions with FDA and I must say that I am really excited about the potential opportunities a program like this might bring for innovation that will bring real patient benefits going forward! This is a BIG DAY for Novel Excipients! Hopefully, in the future, regulators around the world will implement similar concepts to encourage novel excipient development and use for patient benefit!
Click on the link below to go to the FDA’s website which describes what will be involved in the pilot program and for information about how to submit novel excipient candidates for the two year pilot program.