Mark M. Yacura focuses his practice primarily on FDA legal and regulatory matters. He represents his clients before administrative agencies with a similar regulatory mission, including the Center for Medicare and Medicaid Services (CMS), Consumer Product Safety Commission (CPSC), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), and Federal Trade Commission (FTC).
Mark represents domestic and foreign clients operating in the areas of biotechnology, cosmetics, food and dietary supplements, and medical devices and diagnostics, as well as the synthetic pharmaceuticals industry. Mark assists regulated companies with the FDA approval and clearance process, and with regulatory compliance and enforcement issues involving product status issues, labeling, advertising, and current good manufacturing practice laws and regulations. He drafts and negotiates agreements specific to these FDA regulated industries, such as 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)
- Duquesne University (B.S., 1978)
- University of Pittsburgh (M.B.A., 1978)
- District of Columbia
Professional and Civic Activities
- District of Columbia Bar Association (Member)
- American Bar Association (Member)