Naomi Lowy, M.D.

Naomi Lowy, M.D. is a physician with extensive expertise in overseeing the development of drugs and biologics. With an 18-year career at the U.S. Food and Drug Administration (FDA), primarily in the Center for Drug Evaluation and Research (CDER), she held multiple leadership roles in the Office of New Drugs. There, she played a pivotal role in shaping regulatory science and drug development policies, serving as a Division signatory for INDs and NDAs, including multiple new molecular entities for rare endocrine diseases and complex 505(b)(2) applications. She now brings her deep regulatory experience to Hyman, Phelps & McNamara, advising clients on policy matters, clinical trial design, and strategic solutions for complex regulatory challenges.

During her tenure at the FDA, Dr. Lowy served in key leadership positions, including:

• Deputy Director, Division of General Endocrinology: Served as the Division signatory for treatments in growth hormone disorders, rare bone diseases (including achondroplasia), and endocrine conditions affecting the pituitary, adrenal, and parathyroid glands (such as acromegaly, Cushing’s syndrome, and hypoparathyroidism). Her oversight extended to emerging areas such as sarcopenia and cancer cachexia.
• Acting Deputy Director, Division of Anesthesia, Addiction Medicine, and Pain Medicine: Led the regulation of pain products, including addressing the complexities of opioid therapies and novel non-opioid analgesics. Her work included advisory committee presentations, guidance development, and public engagement on critical regulatory issues.
• Associate Director for Regulatory Science, Office of Drug Evaluation 1: Provided regulatory expertise for the Office overseeing Cardiology, Neurology, and Psychiatry. She co-chaired the working group for the Integrated Review template and process, a transformative initiative streamlining drug review and approval.

Dr. Lowy prioritizes clear communication and a collaborative approach, ensuring that regulatory pathways are navigated efficiently while upholding the highest standards of patient safety and therapeutic innovation. Her work is driven by a commitment to advancing treatment options that improve the health and lives of patients. Now, in her role at Hyman, Phelps & McNamara, she leverages her FDA experience to support clients in achieving successful regulatory outcomes across a broad range of therapeutic areas.