Katie E. Kramer

She routinely bridges science and law by supporting clients in developing and drafting strategic communications and regulatory submissions. Her broad experience in written advocacy includes drafting a request for reconsideration involving a complex scientific dispute for a biological product; preparing multiple scientific advocacy documents in connection with a pediatric Written Request; responding to Form FDA 483 inspectional observations; and assisting companies in preparing FDA meeting requests and technical briefing packages. Her background and understanding of FDA regulation and policy, supports clients on the product lifecycle implications of the Inflation Reduction Act’s Drug Price Negotiation Program.

Katie also assists clients on a wide range of compliance matters, including internal investigations related to clinical trial conduct and advertising and promotion practices, and has helped clients’ develop internal policies and guidelines on drug promotion. In addition, she has in-house experience providing legal support to the quality function of a global pharmaceutical company, including negotiating quality agreements with vendors and advising on compliance with Drug Supply Chain Security Act requirements.

Prior to joining the firm, Katie supported a biopharmaceutical contract manufacturing company in preparing for an FDA inspection, assessing the feasibility of research proposals for the International Space Station, and authored multiple peer-reviewed scientific journal articles on tissue biomechanics.