The FDA has issued two proposed rules on investigational new drug applications (IND) that would require more detailed IND reports and exemptions for clinical trials for drug uses of a food, dietary supplement or cosmetic product.

Under the proposed rule on annual reporting requirements, sponsors would be required to provide the agency with a yearly FDA development safety update report (DSUR) that follows the International Council for Harmonization’s (ICH) E2F DSUR guidelines.

The provision would make the yearly update required of sponsors more detailed and comprehensive than the IND annual report currently mandated by FDA regulations. Among a number of elements, the DSUR includes an overall safety analysis and a summary of cumulative safety information.

The rule is being put forward to address the growing complexity of trials. In the agency’s view, requiring a DSUR that assesses risk at a deeper level than the current annual report will help the agency and sponsors identify and manage potential risks, cut down the amount of unnecessary risks trial participants are exposed to and improve the FDA’s assessment of trials conducted outside the U.S.

“Because FDA intends that the DSUR be consistent with the format and content of submission of the DSUR supported by ICH, the annual reporting process for sponsors would be more efficient by supporting one format for submission to FDA and multiple regulatory authorities in the European Union (EU) and other countries and regions,” the proposed rule reads.

The second proposed rule would exempt certain trials of legally marketed foods for human consumption (including conventional food and dietary supplements) and cosmetics from requiring an IND when the product is being studied for use as a drug. This would apply to trials that aren’t meant to support a drug development plan or labeling change and trials that do not present significant risks to participants, among other factors.

The proposed provisions “are intended to reduce the regulatory burden of conducting such studies while retaining protections for human subjects,” the agency said.

Should the proposed rule be finalized, sponsors should be aware that the exempted trials must comply with other regulations meant to protect the rights and safety of participants, including informed consent and IRB review requirements, the agency said.

The comment deadline on the proposed rules is March 9, 2023.

Read the proposed rule on DSURs here: https://bit.ly/3Fcth4h.

Read the proposed rule on IND exemptions here: https://bit.ly/3W1p6iq.