FDA Launches Novel Excipient Review Pilot Program

The Novel Excipient Review Pilot Program will allow excipient manufacturers to obtain FDA review of certain novel excipients prior to use in drug formulations.

On Sept. 7, 2021, The Center for Drug Evaluation and Research (CDER) launched the voluntary Novel Excipient Review Pilot Program, which is designed to give an opportunity to excipient manufacturers to obtain FDA review on certain novel excipients prior to their use in drug formulations.

The program will be initially available for excipients that meet two criteria: they must not have been previously used in FDA-approved products, and they cannot have an established use in food. If an excipient meets these requirements, it can enter the two-stage approval process.

The first stage requires manufacturers to provide a thorough overview of their novel excipients. This includes a description, its proposed use, and the public health or drug development need addressed by their excipient. Factors such as potential public health benefit and novel drug development potential will be considered at this stage.

Of all submissions, CDER intends to accept approximately four initial proposals, but more may be considered as resources allow. If accepted, the second stage consists of providing a full data package consisting of toxicology and quality data.

If interested, applicants should send their proposals to Novel-Excipient-Program@fda.hhs.gov by Dec. 7th, 2021. For a comprehensive breakdown of the application procedure, an outline can be found below “Resources” on the announcement page.

Source: FDA