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.
Articles / Publications
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,
It's the Law: Compliance with FDA's Financial Disclosure Rule,
see more speaking engagements
Tobacco Products, Legal Summit, January 12-13, 2015
Essential strategies for meeting regulatory and litigation hurdles in the manufacturing, marketing, and sale of tobacco products
4th Annual CNS Diseases World Summit, September 18-19, 2014
5 Years of the Tobacco Control Act: Progress and Challenges, April 23-24, 2014
FDLI FDA Regulation of Tobacco Products conference, October 29, 2013
FDA Regulation of Tobacco: A Review of 2013, What to Expect in 2014
Clinical Trial Disclosure: Keeping Ahead of the Wave, June 25, 2013
Webinar presented by Hyman, Phelps & McNamara, P.C. in conjunction with Dechert, LLP.
see more blog entries
Court Finds Three Appointments Tainted the FDA's Tobacco Products Scientific Advisory Committee, Including its Menthol Report,
July 23, 2014
Picking a Proprietary Name for a New Drug is No Simple Task - FDA Issues a Draft Guidance on Best Practices in Developing Proprietary Names,
June 1, 2014
Deem the e-Cigarettes! Full Speed Ahead!,
April 28, 2014
When is a Very, Very Long Delay the Same Thing as a Ban? FDA's Review of Tobacco Product Submissions Under the Microscope,
October 23, 2013
Up in Smoke (or Vapor, as the Case May Be),
September 22, 2013