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 and has contributed to the InsideMedicalDevices blog.
Articles in the National Law Review database by Mingham Ji