Phoebe Mounts

Partner

Phoebe Mounts is a partner in Morgan Lewis's FDA Practice. Her practice is focused on FDA-related regulatory matters, particularly in the area of product development for drugs, biologics, medical devices, and human cell and tissue-based products.

Prior to joining Morgan Lewis, Dr. Mounts was on the faculty of The Johns Hopkins University School of Public Health for 16 years, where she was elected to the Delta Omega Public Health Honorary. She has published more than 45 articles in the areas of molecular biology and infectious diseases and has conducted research on the papillomavirus etiology of tumors of the respiratory and genital tracts. Her scientific background enables her to assist clients with emerging technologies and on issues involving preclinical studies to support product development and presentation of technical manufacturing information. Dr. Mounts prepares submissions to the FDA, including Investigational New Drug (IND), Investigational Device Exmption (IDE) and 510(k) applications, meeting requests, and background packages, and she attends meetings at the FDA with clients to facilitate product development. In addition to preparing clinical trial agreements, consent forms, and assisting in interactions with Institutional Review Boards, Dr. Mounts has conducted audits of clinical trial sites in preparation for FDA review of pivotal clinical trials and provides Good Clinical Practice training. She assists clients with privacy issues for clinical trial data, and has guided implementation of the safe harbor certification program. Dr. Mounts also has prepared applications for orphan drug designation, jurisdictional assignment within the FDA, negotiated Special Protocol Assessments, and assisted clients in appealing decisions by the review division. She has secured reclassification of a medical device, and in 2005, she received an award from the FDA "For outstanding teamwork and leveraging of public and private resources to support the timely down-classification of hepatitis A serological assays." She also is an active participant in the Food and Drug Law Institute/FDA In-House Training Program.

Dr. Mounts is admitted to practice in the District of Columbia and Maryland.