FDA launches Novel Excipient Review Pilot Program to foster development of novel inactive ingredients and address approval challenges
Today, the U.S. Food and Drug Administration (FDA) introduced the Novel Excipient Review Pilot Program, a new pathway for manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) prior to their use in drug formulations.
FDA is aware of the developmental challenges that excipient manufacturers and drug developers have faced regarding formulation and stability issues with the use of certain excipients. With this voluntary pilot program, FDA intends to foster development of excipients that may be useful in scenarios where excipient manufacturers and drug developers have cited prior difficulty in using existing excipients.
The Novel Excipient Review pilot will consist of a two-part selection process to occur over a two-year period. During this two-year pilot phase, FDA will select 2 proposals to proceed through the Novel Excipient Review program each year. The triage and selection process will focus on several criteria, including:
- potential public health benefit of the novel excipient (e.g, excipients that may facilitate opioid abuse-deterrent formulations or excipients that may promote development of new therapies for serious and life-threatening diseases;
- likelihood of the novel excipient manufacturer’s ability to submit a complete package within the timeframe established; and
- overall potential of the novel excipient to meaningfully improve pharmacokinetic characteristics that may lead to novel drug development.
Due to the limited scope of this pilot, FDA is only able to consider proposals for novel excipients that have not been previously used in FDA-approved drug products, and do not have an established use in food.
For more information about the pilot, including an example outline of submission content, visit the Novel Excipient Review Pilot webpage. For questions about the pilot program, email Novel-Excipient-Program@fda.hhs.gov.
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