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# CDER Starts Novel Excipient Review Pilot Program
- URL: https://www.fdaweb.com/cder-starts-novel-excipient-review-pilot-program/
- Published: 2021-09-07T12:00:00.000Z
- Updated: 2026-09-14T17:13:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150085

CDER has started its voluntary Novel Excipient Review Pilot Program to allow excipient manufacturers to obtain agency reviews of certain novel excipients before their use in drug formulations. An online [statement](https://www.fda.gov/drugs/development-approval-process-drugs/novel-excipient-review-pilot-program?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the program will initially be available for excipients that **(1)** have not been previously used in FDA-approved drug products and **(2)** do not have an established use in food. The intent is to foster the development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients, the notice says.

The program has two stages, FDA says. The first is an initial proposal stage for excipient manufacturers to provide a high-level overview of their novel excipient. CDER says it intends to accept four initial proposals and will consider accepting additional proposals as resources allow. Manufacturers whose proposals are accepted would move to the second stage in which they would provide a full package of toxicology and quality data, similar to that provided for an IND.