A new memorandum of understanding between the U.S. Securities and Exchange Commission and the Food and Drug Administration formalizes tighter information sharing for pharmaceutical, biotech and medical device disclosures. Under the MOU, the SEC will draw more directly on FDA expertise during disclosure reviews, while the FDA will more systematically monitor how companies communicate regulatory status and commercial prospects to investors. For public companies, the immediate impact is compliance scrutiny on narrative disclosures. Executives will face heightened expectations around risk factors, MD&A, and how trial results and regulatory milestones are described in press releases. Industry lawyers quoted in the report recommend building a disclosure process with precise language and fact-by-fact backup that can be reviewed by technical and scientific staff at both agencies.
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