David B. Clissold
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 the Food 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.
Prescription Drugs and Biologics
• Develops product lifecycle management strategies for prescription drugs and biologics including Hatch-Waxman exclusivity and orphan drug designations.
• Advises clients on FDA's approval process, including clinical, preclinical, and toxicology protocol development and data presentation.
• Represents drug, device, and biologic product sponsors in meetings with FDA.
• Provides counsel on clinical trial issues, including clinical trial agreements, informed consent, HIPAA patient privacy, IRB relations, reporting of adverse events, and removal of clinical holds.
• Regularly meets with FDA on drug development issues.
• Advises tobacco manufacturers and retailers on the Family Smoking Prevention and Tobacco Control Act, including the regulation of cigarettes, smokeless tobacco, modified risk tobacco products, and other tobacco products.
• Provides guidance on warning labels.
• Conducts investigations into allegations of clinical investigator noncompliance and fraud.
• Develops risk management plans for controlled substances and other products.
• Drafts comments for proposed rules, guidance documents, and citizen petitions to FDA.
• Responds to FDA inspection reports, warning letters, and Application Integrity Policy, and prepares clients for inspections and audits.
• Conducts FDA regulatory due diligence for both corporations and underwriters seeking venture capital and public financing.
Awards & Recognition
• The International Who's Who of Business Lawyers (Life Sciences), Regulatory Section, 2016
Articles / Publications
see more articles
• Bringing Your Pharmaceutical Drug to Market,
April 1, 2015
• Retailers on the Radar of FDA Under the Family Smoking Prevention and Tobacco Control Act,
• The Family Smoking Prevention and Tobacco Control Act: An Overview,
• Abigail Alliance v. von Eschenbach,
March 2, 2007
• What You Say May Be Used Against You,
see more speaking engagements
• Introduction to Tobacco Law and Regulation, Product Compliance: Labeling Requirements, Advertisement, and Promotion, April 6, 2017
• Webinar: 21st Century Cures Act - Pharmaceutical and Biologic Product Development Provisions, January 12, 2017
• Introduction to Tobacco Law and Regulation, Product Compliance: Labeling Requirements, Advertisement, and Promotion, October 26, 2016
• 2014 FDA Regulation of Tobacco, October 21, 2014
• FDA Regulation of Tobacco 2014, October 21, 2014
see more blog entries
• The Final Common Rule: Much Either Retained or Removed, But Not Much New Added,
February 16, 2017
• FDAAA Asked & NIH Answered: The Final Rule on Clinical Trials Registration and Results Reporting,
October 11, 2016
• FDA's Final Deeming Regulations Covers all "Tobacco Products",
May 10, 2016
• DC Circuit Vacates District Court Regarding TPSAC; Is the Menthol Report Back or in Limbo?,
January 16, 2016
• A Year in Review: Important Intel Gleaned from CDER Report on New Drug Approvals,
December 27, 2015