FDA and SEC Compare Notes: What the New MOU Means for FDA-Regulated Public Companies September 8, 2026 By Sarah Wicks & Deborah L. Livornese & Michelle L. Butler —

https://www.thefdalawblog.com/2026/09/fda-and-sec-compare-notes-what-the-new-mou-means-for-fda-regulated-public-companies/?utm_source=rss&utm_medium=rss&utm_campaign=fda-and-sec-compare-notes-what-the-new-mou-means-for-fda-regulated-public-companies On August 31, 2026, FDA and the Securities and Exchange Commission (SEC) announced a new Memorandum of Understanding (MOU) intended to enhance cooperation between the agencies and facilitate the exchange of non-public information relevant to their respective oversight and enforcement responsibilities. The agreement runs for three years and can be extended. For publicly traded life sciences companies, the immediate implication seems obvious: SEC may have an easier way to learn what FDA knows when evaluating what a company has told investors about clinical trial results, regulatory interactions, product approvals, or other FDA-related developments. But FDA and SEC have been sharing this kind of information for more than two decades. So, what exactly is new?