Fox Rothschild LLP is pleased to welcome Mark M. Yacura in Washington, DC as a partner in the Intellectual Property Department. Mark comes to Fox from the DC office of Michael Best & Friedrich, LLP.
“Mark has more than three decades of experience advising domestic and international companies seeking FDA clearance and approval for new products, technology and ingredients,” said Reginald M. Jones, Fox’s DC office managing partner. “His extensive insight into complex compliance and regulatory matters is a welcomed addition to the firm.”
Drawing on his experience with the Food and Drug Administration (FDA), Yacura provides strategic regulatory counsel to clients in the pharmaceutical, medical device, food and beverage, dietary supplements and consumer products sectors, helping regulated companies secure clearances and approvals for drug diagnostics, medical devices and food ingredients. He also advises on compliance and enforcement issues involving product status processes, labeling and advertisement. In the area of Current Good Manufacturing Practice laws (CGMPs), Yacura provides strategic assistance with FDA Warning Letters, adverse inspection observations, product seizures, import alert detentions, recall requests and consent decrees.
Clients also rely on Yacura for FDA due diligence regarding portfolio companies and company acquisitions, as well as for regulatory review of securities filings. His capacities extend to drafting and negotiating agreements within the FDA industry, including licensing, supply and clinical trial agreements.
Beyond FDA matters, Yacura represents companies before a number of federal administrative agencies including the Federal Trade Commission (FTC), Environmental Protection Agency (EPA), Consumer Product Safety Commission (CPSC) and the National Advertising Division of the Better Business Bureau (NAD). Additionally, he assists with advertising claims, substantiation issues and compliance with the Federal Trade Commission Act.
He earned his J.D., cum laude, from American University, his M.B.A. from the University of Pittsburgh and his B.S. from Duquesne University.
