Morgan Lewis

Related Publications

05/08/08 Update on FDA Regulatory/Legislative Issues Impacting Drugs, Biologicals and Medical Devices, presented at the American Health Lawyers Association Life Sciences Law Institute, Bethesda, MD
04/17/08 Changing Landscape of the Regulatory Pathway for Follow-on Biologics, presented at BayBio2008: Doing Well by Doing Right, San Francisco
06/29/07 FDA Regulation of Medical Devices, presented at the D.C. Bar Health Law Section and Litigation Section Off-The-Record Luncheon Program, Washington, D.C.
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Practice Areas

Bar Admissions

  • District of Columbia
  • Maryland
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Phoebe Mounts
Partner

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Email: pmounts@morganlewis.com
Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
Phone: 202.739.5898
Fax: 202.739.3001

Phoebe Mounts is a partner in Morgan Lewis's FDA/Healthcare Regulation Practice. Her practice is focused on food- and drug-related regulatory matters, particularly in the area of product development for biologics, drugs, and medical devices.

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 for drugs and biologics. Her background in oncologic diseases has facilitated her work for clients in the areas of genital tract cancer, prostate cancer, ovarian cancer, liver cancer, melanoma, hematologic malignancies, lung cancer, breast cancer, brain cancer, and head and neck cancer.

Dr. Mounts prepares submissions to the FDA, including Investigational New Drug (IND) 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 also has prepared applications for orphan drug designation, jurisdictional assignment within the FDA, and reclassification of a medical device. 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."

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

Education

  • Georgetown University Law Center, 1999, J.D.
  • Johns Hopkins University, 1980, P.D.F.
  • University of Edinburgh, Scotland, 1977, Ph.D.
  • University of Pittsburgh, 1973, M.S.
  • University of Pittsburgh, 1971, B.S.