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USFDA's Novel Excipient Review Pilot Program

The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which is intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations.


This Pilot Program will 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 Pilot Program will initially be available for novel excipients that

(1) have not been previously used in FDA-approved drug products, and

(2) do not have an established use in food.


It will consist of two stages.


The first stage is an initial proposal stage for excipient manufacturers to provide a high-level overview of their novel excipient.


Excipient manufacturers whose initial proposals are accepted would then enter the second stage, during which they would provide a full data package consisting of toxicology and quality data.


Check out this LINK for “Novel Excipient Review Pilot Program Initial Proposal Model Content Outline”.


Also, refer to Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients” and quality data (chemistry, manufacturing, and controls data) similar to that provided in an investigational new drug application for submitting a full package consisting of toxicology.

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