Expertise in all things FDA
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Expertise in all things FDA
Overview
David B. Clissold has broad-based experience advising pharmaceutical, biotechnology, medical device, food, and dietary supplement clients on regulatory and legislative matters. He provides guidance throughout the product lifecycle, which includes clinical trials and drug development, advertising and promotion, orphan drug designations, and Hatch-Waxman exclusivity. Mr. Clissold also helps clients with a range of enforcement actions, including FDA inspections and Application Integrity Policy actions. In recent years, Mr. Clissold has steered Hyman, Phelps & McNamara’s team of attorneys focusing on FDA’s regulation of tobacco products and nicotine replacement therapies.
Mr. Clissold also advises health care professionals, universities, and medical schools on regulatory compliance issues. He provides pro bono counsel to patient groups and state health care agencies. Mr. Clissold lectures on various FDA topics, including regulation of tobacco products, regulatory obligations in clinical investigations, strategies for developing and marketing drugs and biologics, orphan drugs, and Hatch-Waxman issues. He has presented to the Food and Drug Law Institute, and has published papers in The New England Journal of Medicine, The Journal of Pharmacology and Experimental Therapeutics, Pharmacology, Biochemistry & Behavior, and theFood and Drug Law Journal.
Before joining the firm in 1996, Mr. Clissold conducted clinical and pre-clinical research at Nova Pharmaceutical Corporation and the Johns Hopkins University School of Medicine. Mr. Clissold’s clinical background includes the study of central nervous system disorders, including Alzheimer’s disease, schizophrenia, and rare metabolic disorders.