Hannah Bornstein Email & Phone Number

I counsel life sciences companies through a range of FDA (Food & Drug Administration) and DOJ compliance, enforcement, and litigation matters. Whether assessing a potential product approval pathway, conducting due diligence in a transaction, or responding to a government investigation, I help clients navigate a myriad of complex government regulations and oversight. I counsel clients in matters involving the False Claims Act (FCA); the Food, Drug, and Cosmetic (FD&C) Act; and the Anti-Kickback Statute and in responding to governmental inquiries or investigations conducted by the FDA, the United States Attorney’s Office and the Department of Justice, among others. I bring my experience in enforcement matters to my client's compliance and transactional matters, helping them anticipate - and avoid - potential pitfalls. And on a personal level, I enjoy learning the science behind my clients' products and therapies and helping companies bring innovative, life-changing treatments to market in a compliant way.

Listed skills include White Collar Criminal Defense, Internal Investigations, Civil Litigation, and False Claims.