Disclosure Issues and SEC Enforcement Trends in Connection with Clinical Trials and FDA Regulatory Communications
FDA-regulated firms frequently face challenging securities disclosure questions. With an increasingly risk-averse FDA, companies are faced with questions of whether and how to disclose clinical trial findings, FDA advisory committee proceedings, and regulatory interactions and communications, including FDA "Complete Response Letters." Experienced practitioners from Ropes & Gray's Life Sciences and Securities Litigation Practice Groups will explore difficult disclosure issues and best practices associated with clinical trials and interactions with regulators. We will discuss when and what needs to be disclosed along the way as a clinical trial progresses and the results become available, as well as best practices for ensuring full and frank consideration of the relevant issues at disclosure points. We will also address trends and considerations related to when companies need to make disclosures associated with interactions with key regulators. Finally, we will discuss FDA and SEC cooperation on issues of disclosure and enforcement trends in related SEC litigations.