CDER Conversations
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.
On December 5, 2019, a Request for Information (RFI) was posted in the Federal Register to gather input from industry to evaluate interest in developing a pilot program and to identify potential challenges. FDA considered this public feedback in developing this pilot.
In this CDER Conversation, Karen Davis Bruno, PhD, OND Associate Director of Pharmacology/Toxicology, speaks about the Novel Excipient Review Pilot Program.
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