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Mingham Ji advises pharmaceutical, biotechnology, and medical device clients on a broad range of regulatory, legislative, and compliance issues before FDA and other regulatory agencies. Ms. Ji has particular experience counseling clients on strategic considerations around engagement with and advocacy before FDA, including through formal dispute resolution proceedings, comments to public dockets, and other submissions to the agency. Her work in this area has spanned both drug development and post-approval issues, including pediatric testing requirements and pediatric exclusivity, risk management and pharmacovigilance, data transparency, and manufacturer communications. Ms. Ji also actively participates in Covington’s multidisciplinary Digital Health Initiative.

  • 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.

Pro Bono

  • Successful representation of a U visa holder in her application for legal permanent residency.
  • Provided legal information during walk-in clinics for landlord/tenant issues at Bread for the City and through the DC Bar Pro Bono Program’s Landlord-Tenant Resource Center.