The Harvard Law School Forum on Corporate Governance https://corpgov.law.harvard.edu The leading online blog in the fields of corporate governance and financial regulation. Thu, 24 Sep 2026 11:32:11 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.11 https://corpgov.law.harvard.edu/wp-content/uploads/2024/02/cropped-photography-4-e1706898544564-1-32x32.png FDA and SEC Open a New Information-Sharing Channel: Implications for Public Life Sciences Companies – The Harvard Law School Forum on Corporate Governance https://corpgov.law.harvard.edu 32 32 FDA and SEC Open a New Information-Sharing Channel: Implications for Public Life Sciences Companies https://corpgov.law.harvard.edu/2026/09/22/fda-and-sec-open-a-new-information-sharing-channel-implications-for-public-life-sciences-companies/?utm_source=rss&utm_medium=rss&utm_campaign=fda-and-sec-open-a-new-information-sharing-channel-implications-for-public-life-sciences-companies https://corpgov.law.harvard.edu/2026/09/22/fda-and-sec-open-a-new-information-sharing-channel-implications-for-public-life-sciences-companies/#respond Tue, 22 Sep 2026 11:30:43 +0000 https://corpgov.law.harvard.edu/?p=183872?d=20260921124117EDT Posted by Paul Rubin, Paul Rodel, and Melissa Runsten, Debevoise & Plimpton LLP, on Tuesday, September 22, 2026
Editor's Note:

Paul Rubin and Paul Rodel are Parterns, and Melissa Runsten is a Counsel at Debevoise & Plimpton LLP. This post is based on their Debevoise memorandum.

Key Takeaways:

  • The U.S. Food and Drug Administration and Securities and Exchange Commission recently announced a new three-year Memorandum of Understanding (“MOU”) establishing a formal framework for the agencies to exchange nonpublic information concerning FDA-regulated products, activities and companies.
  • For pharmaceutical, biotechnology and medical-device companies that are publicly traded or otherwise are SEC-reporting companies, the MOU could have significant implications for disclosures concerning clinical trials, FDA interactions, product approvals, manufacturing and inspection developments, and other regulatory matters that may be material to investors.
  • Although the MOU does not change the securities-law disclosure standard, it likely makes it easier for SEC staff to test a company’s account of an FDA interaction against FDA’s own contemporaneous record.

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