Mingham Ji advises biopharmaceutical companies, health care and data analytics organizations, and trade associations on FDA regulatory and policy matters.

In her work with these clients, Mingham regularly:

• Advises on a broad range of substantive FDA regulatory issues, including the use of real-world evidence for regulatory decision-making, drug safety and pharmacovigilance requirements, and supply chain requirements for prescription drugs.
• Works with companies and trade associations at all stages of the legislative process, including the development of legislative solutions and analyzing proposed legislation.
• Advises companies on appeals of FDA decisions, including formal dispute resolution proceedings and requests for reconsideration.
• Develops comments to FDA for industry trade associations and individual companies on FDA regulatory topics.
• Counsels companies on the Freedom of Information Act and the protection of trade secrets and confidential commercial information submitted to FDA.

Mingham also maintains an active pro bono practice at Covington, with a particular focus on reproductive rights matters and assisting DC residents with landlord/tenant issues.