Daniel A. Kracov

Partner

Washington, D.C. Tel +1 202.942.5120

Dan Kracov is chair of the firm's Life Sciences Industry practice, which was honored by Law360 in 2020 and 2022 as a "Life Sciences Practice Group of the Year." For decades, he has been one of the foremost Food and Drug Administration lawyers in the country, and his expertise in critical regulatory matters has been widely recognized by Chambers, the Legal Times, Best Lawyers in America, and many other publications. Most recently, Dan received the Food and Drug Law Institute (FDLI) Distinguished Service and Leadership Award. A particular focus of his practice is assisting pharmaceutical, biotechnology, medical device, and diagnostic companies, including start-up companies, trade associations, and large manufacturers, negotiate challenges relating to the development, approval, and marketing of FDA-regulated products.

In addition to day-to-day counseling on regulatory and compliance strategies and concerns, Dan regularly handles product and compliance-related government and internal investigations, the development of global corporate compliance programs, and due diligence in financings, mergers, and acquisitions. He also has a widely recognized experience in biomedical public policy matters, including Congressional investigations and advising on FDA-related legislation.

Focus Areas

Experience

Major pharmaceutical and medical device companies in responding to critical regulatory matters, including approval strategies, inspections, investigations, and FDA Advisory Committee meetings.
Major pharmaceutical companies in a variety of FDA legislative initiatives, including the reauthorization of the Prescription Drug User Fee Act and amendments to Hatch-Waxman generic drug legislation.
Leading medical device company in responding to regulatory aftermath of product-related public health crisis.
Numerous companies in FDA/U.S. Department of Justice investigations, product recalls, inspections, import detentions, and other compliance and enforcement matters.
Counsel in the leading case determining the distinction between a drug product and dietary supplement.

Major pharmaceutical company in negotiating settlement after termination of multiyear collaboration agreement with a biotech company.
Major specialty chemical company in seeking inclusion of an active ingredient in a developing over-the-counter drug monograph.
Major over-the-counter (OTC) drug/dietary supplement/cosmetic company in seeking a novel Rx-to-OTC switch.
Multiple Congressional investigations, as lead counsel, relating to drug safety and off-label marketing.
Scientific investigators in the aftermath of the death of clinical study subject. Represented investigators in five separate governmental and private investigations.
Leading medical device Internet retailer in FDA, U.S. Federal Trade Commission (FTC) and state regulatory matters.
Major pharmaceutical company in achieving U.S. Department of Defense policy on procurement of terrorism countermeasure, and in efforts to secure stockpiling of a pandemic countermeasure product.