SEC and FDA Formalize Information-Sharing Framework: What FDA-Regulated Public Companies Need to Know

Public companies in the life sciences sector have long faced enforcement risk from the U.S. Securities and Exchange Commission (SEC) and the risk of shareholder litigation stemming from alleged misstatements or failures to disclose material information and other alleged violations of securities laws. Recently, the SEC and the U.S. Food and Drug Administration (FDA) signed a Memorandum of Understanding (MOU) that increases the likelihood of agency enforcement and shareholder litigation if there…
By: Haynes Boone