Same Record, Two Regulators – What the New SEC-FDA MOU Means for Your Disclosures

On August 31, 2026, SEC and FDA signed an MOU to formalize a framework for sharing nonpublic information about FDA-regulated products and the companies that make and sell them. The SEC can request FDA meeting minutes, Complete Response Letters, and review division correspondence, so what a company tells investors about its FDA interactions can be checked against the FDA’s own file, to use in SEC investigations and resulting actions. To a greater degree than in the past, the SEC is scrutinizing areas that may not have historically seen significant SEC activity. FDA is also increasingly aware of how the matters it oversees may assist SEC in enforcing securities laws. Please join us as we discuss the MOU and what this may mean for life sciences companies going forward.

Hear from our FDA and securities lawyers on:

• FDA perspective. What the FDA holds that the SEC can now reach, how requests are handled, what stays protected, what matters FDA may refer to the SEC (including clinical trial information and inspection matters), and how FDA may use information shared by the SEC.
• Securities perspective. How the SEC may use this information in investigations and enforcement and the heightened disclosure risk that this development brings.
• Disclosures and the FDA record. Where statements on review status, approvals, and clinical results can diverge from the file, shown through hypotheticals.