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  • October 7, 2026
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CDER Conversation: Novel Excipient Review Pilot Program

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)

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