Dan Kracov heads the FDA and Healthcare practice. He assists clients, including start-up companies, trade associations, and large manufacturing companies, in negotiating the challenges relating to the development, approval and marketing of drugs, biologics, and medical devices. His experience in US Food and Drug Administration (FDA) strategic advice and crisis management won him a spot on the Fall 2005 Legal Times list of "Leading Lawyers in Food & Drug Law."

Mr. Kracov regularly handles product and compliance-related investigations, the development of regulatory corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely recognized experience in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislative strategies.

Experience

  • 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.
  • Numerous companies in FDA/US Department of Justice investigations, product recalls, inspections, import detentions, and other compliance and enforcement matters.
  • Leading medical device Internet retailer in FDA, US Federal Trade Commission (FTC) and state regulatory matters.
  • Major pharmaceutical company in achieving US Department of Defense policy on procurement of terrorism countermeasure, and in efforts to secure stockpiling of a pandemic countermeasure product.
  • Range of companies in advertising investigations brought by the FTC and State Attorneys General. 

Perspectives

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
The Naming Game: FDA Releases Draft Guidance, Proposed Rule on Biological Names
Arnold & Porter Advisory
More

Recognition

The Best Lawyers in America 2016 for Health Care Law

The Best Lawyers in America 2007-2016 for FDA Law

Chambers USA: America's Leading Lawyers for Business 2008-2015 for Healthcare: Pharmaceutical/Medical Products Regulatory (DC)

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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