Phoebe Mounts counsels companies developing drugs, biologics, medical devices, and human cell and tissue-based products on US Food and Drug Administration (FDA) regulations. Her scientific background enables her to assist clients with product approvals for emerging technologies, such as combination products and companion diagnostics, including counseling on regulatory pathway issues and developing preclinical and clinical studies. Phoebe prepares submissions to the FDA, including applications for orphan-drug designation, humanitarian device exemptions (HDEs), investigational new drugs (INDs), investigational device exemptions (IDEs), and 510(k)s, as well as meeting requests and background packages.
Phoebe assists clients with special protocol assessments, clinical trial agreements, informed consent forms, and interactions with Institutional Review Boards. She also provides good clinical practice (GCP) training and audits clinical trial sites in preparation for FDA review. She helps clients address privacy matters related to clinical trial data, and guides them through the implementation of the Safe Harbor certification program.
Additionally, Phoebe assists clients appealing decisions by the agency’s review divisions, and responding to allegations of scientific integrity of research and development programs.
Phoebe’s experience includes securing reclassification of a medical device and, in 2005, she received an FDA award “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.
Prior to joining Morgan Lewis, Phoebe was a faculty member of The Johns Hopkins University School of Public Health for 16 years, and was elected to the Delta Omega Honorary Society in Public Health. She has published more than 45 articles in the areas of molecular biology and infectious diseases.