Hogan & Hartson’s pharmaceutical and biotechnology clients rely on our global regulatory experience in their domestic and international business transactions. Based on substantial scientific and government experience, our attorneys provide legal and strategic advice to clients from the preclinical development stage through the most beneficial approval pathways and the myriad of postmarketing obligations. With the assistance of our intellectual property, corporate and licensing, health, and litigation colleagues, we provide integrated, practical advice for successful product development and marketing.

Our clients include large pharmaceutical and biotechnology companies, smaller innovative organizations, and entrepreneurs with compelling new ideas and technology. We advise on products that range from traditional new drugs to biotechnology products, including controlled substances, tissue and cellular therapies, and innovative combination products. Our intimate knowledge of government standards and practices as well as the breadth of our industry knowledge affords our clients unmatched resources for their product development, approval, and marketing needs.

Former Leadership Positions

• Bob Brady, David Fox, Joe Levitt, Meredith Manning, Rick Silverman, Mike Druckman, and Robert Church all former Associate Chief Counsels for Enforcement at the FDA
• Joe Levitt, former Director, Center for Food Safety and Applied Nutrition, FDA and Deputy Director for Regulations and Policy at the FDA's Center for Devices and Radiological Health as well as Executive Assistant to the FDA Commissioner and other senior positions in the Commissioner's office
• David Fox, former FDA Associate Chief Counsel for the Center for Drug Evaluation and Research
• Marc Bozeman, former Director of the Office of Compliance for the Bureau of Biologics and former FDA Deputy Chief Counsel for Administration
• Linda Horton, former advisor to the FDA’s Acting Deputy Commissioner and FDA Director of International Policy, Deputy Chief Counsel for Regulations and Hearings, Associate Chief Counsel for Medical Devices, and Chief of the FDA’s legislative branch
• Bob Brady, former Associate Chief Counsel for Foods and Associate Chief Counsel for Biologics at the FDA, and former Executive Assistant to the FDA Commissioner
• Meredith Manning, former Assistant U.S. Attorney, U.S. Attorney's Office, District of Columbia
• Mike Druckman, former Associate Chief Counsel for Enforcement and former Associate Chief Counsel for Biologics at FDA’s Office of the Chief Counsel (OCC)
• Ed Korwek holds a Ph.D. in biochemistry; his thesis and postdoctoral work was in molecular biology
• Robert Church, former Associate Chief Counsel for Drugs and former Associate Chief Counsel for Enforcement at FDA’s Office of the Chief Counsel (OCC)