Dan Kracov is co-chair of the Life Sciences and Healthcare Regulation 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

Senate HELP Committee Approves 19 Bills on Medical Innovation as House Adds Directives to FDA's 2017 Appropriations Bill
Arnold & Porter Advisory
Hot Global Compliance Topics in the Pharmaceutical and Medical Device Sectors: Controlling Evolving Risks
Arnold & Porter LLP
The Trans-Pacific Partnership Agreement Would Affect Diverse Sectors of the Global Economy
Arnold & Porter Advisory
Using CRO's for Multinational Clinical Trials: Best Practices for Staying Competitive and Compliant
Thompson Information Services
FDA's Evolving Framework for Oversight of Next-Generation Sequencing
Arnold & Porter Advisory
More

Recognition

Washington, DC Super Lawyers 2014-2016 for FDA Law

The Best Lawyers in America 2016 for Health Care Law

The Best Lawyers in America 2007-2016 for FDA Law

More

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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