Jae's experience includes:

  • Advising on product recall management and preparing recall-related submissions to FDA;
  • Advising on FDA's adverse event reporting requirements;
  • Counseling on state and federal permit and registration issues (FDA, DEA, TTB, CLIA, State Board of Pharmacy);
  • Conducting legal review of labeling and marketing claims on foods and medical products based on FDA and FTC requirements;
  • Drafting quality agreements involving contract manufacturers and raw material suppliers (cGMP/ISO);
  • Providing strategic guidance on FDA's premarket approval or clearance process, including assessment of applicable product classification;
  • Preparing responses to FDA Form 483 observations;
  • Coordinating regulatory advice from counsel in Canada, Europe, Asia, and Latin America for clients with regulated products in multiple ex-U.S. jurisdictions; and
  • Significant experience in conducting FDA/DEA/USDA regulatory due diligence in transactions on behalf of clients in corporate transactions involving regulated products.