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Mingham Ji

Special Counsel

Washington +1 202 662 5621

  • About
  • Representative Matters
  • Credentials
  • About

    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.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Successful representation of a major pharmaceutical company in formal dispute resolution proceedings regarding eligibility for pediatric exclusivity and the issuance of a complete response letter.
    • Outside counsel to PhRMA on FDA regulatory aspects of the FDA Reauthorization Act of 2017 and the 21st Century Cures Act.
    • Represented Gilead Sciences in FOIA litigation in Connecticut to prevent release of proprietary information concerning its Hepatitis C drug products.
    • Prepared a successful request for FDA’s reconsideration of a rejected proprietary name.
    • Represented biopharmaceutical and medical device companies in the preparation of successful trade complaints to FDA regarding violative advertising and promotion materials.   

    • Conducted internal investigations for multinational pharmaceutical companies to assess complaints relating to data integrity, patient advocacy groups, and the preparation of a pivotal clinical study report and peer-reviewed publication.
    • Develop comments to public FDA dockets for industry trade associations and individual companies on a range of FDA regulatory issues including pediatric testing requirements, advertising and promotion, compounding, the drug supply chain, and proprietary and nonproprietary naming.    
    • Conducted regulatory due diligence on pharmaceutical and medical device companies.

    Areas of Expertise

  • Credentials
    Education
    • The University of Chicago Law School, J.D., 2012
        • The University of Chicago Legal Forum, Articles Editor
    • Amherst College, B.A., 2009
        • summa cum laude
        • Stephen E. Whicher Prize
        • John Woodruff Simpson Fellowship
    Bar Admissions
    • District of Columbia
    • New York
    Languages
    • Mandarin

    Areas of Expertise

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