I counsel FDA-regulated clients in regulatory, enforcement and policy matters that have the potential to materially impact their business.
Tina Papagiannopoulos assists clients with a variety of regulatory, policy, and compliance matters related to the U.S. Food & Drug Administration (FDA) and the Federal Trade Commission (FTC), with a primary focus on therapeutics. She advises clients about product development and regulatory approval, marketing exclusivities, advertising and promotion, post-approval obligations, and responding to enforcement actions and investigations. She counsels clients on effective engagement with the FDA through formal agency meetings as well as through public comment and petitioning processes. She also provides subject-matter expertise on various litigation and transaction matters involving life sciences companies.