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.
