Irving L. Wiesen, Esq. is a food and drug attorney with over thirty years experience in the industry. He specializes in food and drug law and other laws and regulations affecting the pharmaceutical, biotech and medical device industries. His practice includes counseling pharmaceutical and medical device companies in all areas of FDA compliance, drug marketing and promotion, drug applications, representation before the FDA, as well as licensing, R&D agreements, commercial transactions and litigation. Previously, he was a partner in the New York law firm of Bass & Ullman. Prior to that, he was Division Counsel of Boehringer Ingelheim Pharmaceuticals. He also served as Technical Counsel for the National Association of Pharmaceutical Manufacturers, the first trade association of the generic drug industry. He has published and lectured widely in food and drug law.
Mr. Wiesen serves on the advertising review boards of several pharmaceutical companies to ensure that their marketing and promotion complies with FDA regulations. In addition, he has filed successful applications to the FDA on behalf of medical device companies, and obtained marketing clearance for devices in the fields of cardiology and wound-healing. He has also litigated extensively in Federal and state court primarily on matters in the pharmaceutical context, and served as a pharmaceutical regulatory expert in several litigations as well. He also specializes in counseling startup companies in the early phases of drug and device development with respect to the regulatory framework and strategies for pursuing regulatory approval. Mr. Wiesen also appears in allied matters before the Federal Trade Commission, the Drug Enforcement Administration, and the Office of the U.S. Attorney.