CDER Conversation: Novel Excipient Review Pilot Program
FDA’s Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) recently launched a pilot program on Novel Excipient Review. The pilot program offers a new pathway for drug manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) before the excipients are used in drug formulations.
In this CDER Conversation, Karen Davis Bruno, PhD, OND Associate Director of Pharmacology/Toxicology, speaks about the Novel Excipient Review Pilot Program.
The intention of the pilot is to evaluate novel excipients for specific contexts of use that address drug development needs. We’re hopeful the pilot will encourage innovation through incentivizing use of novel excipients in drug development by demonstrating use and safety for potential developers.
Submission is 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. FDA will accept submissions through December 7, 2021.
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