Melissa Mannion is a seasoned regulatory attorney and pharmacist with more than a decade of governmental experience advancing public health through compliance, enforcement, and policy development and implementation. She has in-depth experience as a strategic counselor who is resourceful and creative in identifying solutions that have firm legal and regulatory foundations and who supports scientific advancements to drive progress and productivity.
Prior to joining Jones Day in 2025, Melissa served with the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). During this time she represented the FDA domestically and internationally on matters related to the development of high-quality generic drugs and the global distribution of human drugs, led agency-wide development of programs under the Drug Supply Chain Security Act, and testified as an expert witness during criminal proceedings involving violations of the Food, Drug & Cosmetic Act (FD&C Act) and other related federal statutes.
Her experience also includes resolving complex regulatory hurdles in support of timely review and approval of abbreviated new drug applications (ANDAs); fostering international regulatory alignment on clinical studies and the development of complex drugs and drug-device combination products; collaborating with international health regulatory agencies to combat the rise of substandard, falsified, and counterfeit medical products; responding to incidents and recalling potentially harmful and ineffective drugs to protect patient safety and secure the integrity of the U.S. drug supply chain; addressing drug import and export compliance challenges; and investigating unlawful sales of prescription drugs on the internet.
- University of Maryland, Baltimore (J.D. 2013, with a concentration in Health Law; Doctor of Pharmacy 2012); University of California, San Diego (B.S. in Human Biology and B.A. in Psychology 2006)
- Admitted in California and Maryland State Board of Pharmacy Pharmacist; not admitted in District of Columbia; supervised by a licensed D.C. Bar Member
- Served with the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) from 2013 to 2025 in the following positions: Senior Regulatory Counsel and Regulatory Counsel, Office of Generic Drug Policy; Acting Branch Chief, Recalls and Shortages Branch, Office of Drug Security, Integrity, and Response; Acting Branch Chief, Imports Exports Compliance Branch; and Regulatory Counsel and Pharmacist, Supply Chain Strategy and Policy Branch
发送前请注意
*Information on www.jonesday.com is for general use and is not legal advice. The mailing of this email is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Anything that you send to anyone at our Firm will not be confidential or privileged unless we have agreed to represent you. If you send this email, you confirm that you have read and understand this notice