Mwango A. Kashoki, M.D., MPH

Mwango draws on over 16 years of drug review, development and regulatory experience at FDA, with proven expertise in development of analgesic and addiction (alcohol and opioid) therapies, as well as in post-approval activities including, pharmacovigilance, risk management, and Phase 4 studies. Mwango has strong knowledge of review and development of small molecules and biologics, OTC products, and generics.

Work Experience

Prior to joining Parexel, Mwango was the Associate Director for Safety in the Office of New Drugs (OND), in the Center for Drug Evaluation and Research (CDER) and was responsible for ensuring OND’s implementation of the policies and processes related to CDER’s various safety initiatives, including the Safety First and Sentinel Initiatives. She also led OND’s implementation of FDA’s new authorities to require safety labeling changes, post-marketing investigations, and risk evaluation and mitigation strategies, as provided under the FDA Amendments Act (FDAAA). Before that, Mwango was a Senior Medical Reviewer and Team Leader within OND’s Division of Anesthesia, Analgesia, Addiction and Rheumatology Products.

Education

Mwango holds an M.D. from the Johns Hopkins University School of Medicine, and an M.P.H. from the Columbia Mailman School of Public Health. She is board certified in Preventive Medicine and General Public Health.