Sidley has extensive experience in the Food, Drug and Medical Device Compliance and Enforcement arena and is top-ranked by Chambers USA, Chambers Global and PLC Life Sciences Handbooks for the depth of the practice. 

Contacts

A number of our lawyers have worked at government agencies in various senior positions, including:

  • Former Chief Counsel of the U.S. FDA
  • Associate Chief Counsel of the U.S. FDA
  • Health Policy Advisor to the Senate Committee of Health, Education, Labor and Pensions (HELP), previously Staff Attorney in the Office of the Chief Counsel at FDA and in the Office of the Commissioner of Food and Drugs
  • Staff Attorney/Special Assistant to the Chief Counsel of FDA
  • Assistant Commissioner at the FDA
  • FDA Staff Attorney/Special Assistant United States Attorney
  • Counselor in the Office of the Commissioner at the FDA, previously the Deputy Director for Policy in the Center for Devices and Radiological Health, FDA Legislative Counsel and Parliamentarian to the House Energy and Commerce Committee
  • Head of the FDA Special Prosecution Task Force
  • a member of the European Commission’s Legal Service with responsibility for review of all food- and drug-related proposals
  • an official in the European Commission’s Directorate General for Health and Consumers

Achievements

  • The 2020 edition of U.S. News – Best Lawyers “Best Law Firms” honored Sidley with its “Law Firm of the Year” designation in the FDA Law category.
  • Since 2008, Sidley has continuously been recognized by Chambers Global and Chambers USA in its Global Life Sciences and National Life Sciences rankings. Sidley also received national and state rankings in two specific life sciences regulatory disciplines: Life Sciences: Regulatory and Compliance and Healthcare: Pharmaceutical/Medical Products Regulatory.
  • Highly recommended by LMG Life Sciences in: Regulatory: FDA: Pharmaceutical, and Regulatory: Healthcare: Pricing and Reimbursement in 2019.
  • Coleen Klasmeier was nominated by LMG Life Sciences for “Regulatory Attorney of the Year: FDA Pharmaceuticals” in 2019. The team also received nominations in the “Regulatory” and “US Life Cycle” categories.
  • Deepti Kulkarni (Partner: Food and Drug Law) has been named a “D.C. Rising Star” by The National Law Journal.
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