Drugs

Attorneys Discuss New FDA Draft NCI Guidance

A 3/2026 FDA draft guidance, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers, outlines the agency’s approach to determining new clinical investigation exclusivity. In an online post, attorneys Aziz Burgy and Aaron Savit (Axinn) say the draft guidance also suggests some strategies for maximizing possible NCI exclusivity that could result from in vivo studies conducted by an applicant.

To qualify for NCI exclusivity, the attorneys write, an NDA or sNDA must (1) contain a new clinical investigation that is not a bioavailability study, (2) have a clinical investigation that has been conducted or sponsored by the applicant; and (3) have a clinical investigation that is “essential to the approval” of the NDA or sNDA.

FDA highlights some ways in which in vivo studies may be designed to maximize the opportunities for NCI exclusivity. First, it says that methods for a bioavailability study can vary, and such studies may still qualify for NCI exclusivity if they also include information supporting the proposed drug’s safety or effectiveness. This must go beyond routine safety monitoring and should be reflected in the study prospectively, including its endpoints, design, and/or role in the evidentiary package, the attorneys say.

Clinical investigations that were previously submitted to FDA may still be considered new clinical investigations for purposes of NCI exclusivity, provided that (1) the results have not been previously relied on by FDA to establish effectiveness for any indication or safety in a new population, and (2) the results are not duplicative of another investigation on which FDA did rely.

The agency further outlines how studies may be prospectively designed to examine different cohorts or treatment arms such that a single trial may be used to obtain more than one period of NCI exclusivity. Even if FDA previously relied on a particular study to approve an application or supplement, the attorneys write, a cohort or treatment arm may qualify a drug for NCI exclusivity if it otherwise meets the requirements. They say that to make this determination, FDA considers factors including the scientific or medical reason for the separate cohort, whether the cohort evaluates different patient populations or drug products, and whether the cohort is prespecified in the protocol.

The post contains specific takeaways for 505(j) and 505(b)(2) applicants and concludes that through thoughtful consideration of the regulatory landscape and prospective design of in vivo studies, 505(j) and 505(b)(2) applicants may be able to leverage distinct parts of a single study to qualify for multiple periods of NCI exclusivity across one or several drug products.

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