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# FDA Outlines Novel Excipient Pilot Program
- URL: https://www.fdaweb.com/fda-outlines-novel-excipient-pilot-program/
- Published: 2021-10-08T12:00:00.000Z
- Updated: 2026-09-14T17:18:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150330

A new FDA pilot program on using novel excipients aims to increase their use, especially if they have potential public health benefits. The pilot was initiated after the agency continually heard that drug developers may fear that introducing novel excipients could cause problems or delays with their drug applications, according to an [online post](https://www.fda.gov/drugs/news-events-human-drugs/cder-conversation-novel-excipient-review-pilot-program?utm%5Fmedium=email&utm%5Fsource=govdelivery) by CDER Office of New Drugs associate director of pharmacology/toxicology **Karen Davis Bruno** *.*  

The pilot’s goal is to assess the value of an excipient program in promoting drug innovation through the use of novel excipients. “We will evaluate novel excipients for specific proposed uses that address specified drug development needs and encourage innovation through use of novel excipients in product development,” Bruno said. “Areas identified being impacted by novel excipients are bioavailability, solubility, drug delivery, pediatric formulas and continuous manufacturing.”

Pilot submissions are voluntary and intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. Those interested can find more information on the [Novel Excipient Review Pilot Program Web page](https://www.fda.gov/drugs/development-approval-process-drugs/novel-excipient-review-pilot-program?ref=fdaweb.com). FDA will accept submissions through 12/7.