Dan Kracov is co-chair of the Life Sciences and Healthcare Regulatory practice, which was recently named the top Healthcare practice in the country by Law360. 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 other publications. 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. He also has extensive experience in matters relating to foods, dietary supplements and cosmetics.

In addition to day-to-day counseling on regulatory strategies and concerns, Mr. Kracov 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 has a widely recognized experience in biomedical public policy matters, including Congressional investigations and advising on FDA-related legislation.

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.
  • 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 setting up European regulatory operations.

Perspectives

FDA Seeks Comments on Transition of Certain Drugs to Device Status Following Genus DC Circuit Decision
Advisory
Update: Use of Real-World Evidence in FDA Approvals and Product Promotion
Advisory
Pharmaceutical Advertising 2021: USA Chapter (pdf)
International Comparative Legal Guide to: Pharmaceutical Advertising Laws and Regulations 2021, 18th Edition (London: Global Legal Group, Ltd.)
Real-World Evidence and Its Use in Advertising of Medicinal Products in the EU and US (pdf)
International Comparative Legal Guide to: Pharmaceutical Advertising Laws and Regulations 2021, 18th Edition (London: Global Legal Group, Ltd.)
The VALID Act & 21st Century Cures 2.0: What Industry Needs to Know
Advisory
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Recognition

Chambers USA
Healthcare: Pharmaceutical/Medical Products Regulatory (DC) (2008-2021)
Life Sciences: Regulatory/Compliance (Nationwide) (2018-2021)
Chambers Global
Life Sciences: Regulatory/Compliance (USA) (2021)
Life Sciences: Regulatory/Compliance (Global-wide) (2018, 2020)
The Legal 500 US
Cannabis (2021)
Healthcare: Life Sciences (2013-2021)
Healthcare: Service Providers (2017-2018, 2021)

 

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Credentials

Education
  • JD, University of Virginia School of Law, 1988
  • BA, University of Maryland, 1985, magna cum laude
Admissions
  • District of Columbia
Activities
  • Member, BNA Advisory Board

  • Member, Rx Compliance Report Editorial Advisory Board

Overview

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