A member of the Firm's Intellectual Property group, Mr. Yacura offers clients more than 30 years of strategic regulatory counsel to domestic and international clients in the pharmaceutical, biologics, medical device, conventional food and beverage, dietary supplements, cannabis/CBD products as well as OTC drug, cosmetics and other consumer products sectors.
Based upon his previous experience at the Food and Drug Administration (FDA), Mr. Yacura advises clients navigating complex regulatory issues, premarket approval/clearance processes as well as compliance and enforcement challenges. He represents clients in a variety of areas, including synthetic pharmaceuticals, biotechnology, medical devices, cannabis, conventional foods, dietary supplements and cosmetics.
Mr. Yacura helps regulated companies secure clearances and approvals for drugs, diagnostics, food ingredients, and medical devices, including those involving electromagnetic compatibility. He also advises on FDA and FTC compliance and enforcement labeling and advertising requirements and claims. He represents clients before the FDA regarding product regulatory status, Current Good Manufacturing Practices (cGMP) compliance/enforcement matters as well as adulteration and misbranding issues. Mr. Yacura provides strategic assistance with FDA Warning Letters, adverse inspection observations, product seizures, import alerts and detentions, recall requests and consent decrees.
Clients also rely on Mr. 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 master services, consulting, licensing, supply and clinical trial agreements.
Beyond FDA matters, Mr. 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.