Mark M. Yacura focuses his practice primarily on FDA legal and regulatory matters. He has practiced in this area for more than 30 years. He represents his clients before administrative agencies with a similar regulatory mission, including the Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), as well as the National Advertising Division of the Better Business Bureau (“NAD”).
Mark counsels and represents domestic and foreign clients before the FDA that operate in the areas of 1) synthetic pharmaceuticals, 2) biotechnology, 3) diagnostics, 4) medical devices, 5) conventional foods, 6) dietary supplements, and 7) cosmetics. Mark assists regulated companies with the FDA approval and clearance process for drug products, diagnostics, medical devices and food ingredients. Mark also helps clients with regulatory compliance and enforcement issues involving product status issues, labeling, advertising, and current good manufacturing practice laws and regulations. This includes responding to FDA Warning Letters, adverse inspection observations, product seizures, import alerts, product detentions, recall requests, and consent decrees. Mark also counsels and represents clients with respect to advertising claims and substantiation and compliance with the Federal Trade Commission Act. He similarly represents clients before the NAD. Moreover, Mark assists clients with FDA due diligence on portfolio companies for investor groups and acquiring companies and he has expertised the FDA regulatory sections of various securities filings. Mark drafts and negotiates agreements specific to these FDA regulated industries, such as collaboration licensing, supply, and clinical trial agreements. Prior to entering private legal practice, Mark served at the FDA.
Education and Honors
- American University Washington College of Law (J.D., cum laude, 1985)
- University of Pittsburgh (M.B.A., 1978)
- Duquesne University (B.S., Pharmacy, 1978)
- District of Columbia
Professional and Civic Activities
- District of Columbia Bar Association (Member)
- American Bar Association (Member)