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Anthony T. Pavel

Partner
+1.202.778.9089
Fax +1.202.778.9100

Tony Pavel is a partner in the Food and Drug Practice, providing regulatory counseling on food, drug, cosmetic and medical device products.   Mr. Pavel assists clients with the preparation of FDA submissions, including 510(k) premarket notifications, premarket approval applications, recalls and market withdrawals, food additive petitions, GRAS self-affirmations and notifications, adverse event reports, and product listings and establishment registrations.  Mr. Pavel also has significant experience with regulatory issues involving Over-The-Counter drug products, clinical trials, clinical laboratories, e-health and telemedicine.

Mr. Pavel’s experience includes federal, state, and international regulation of FDA-regulated products and activities, and interaction with the U.S. Food and Drug Administration, the Federal Trade Commission, the U.S. Department of Agriculture, the Alcohol and Tobacco Tax and Trade Bureau, the U.S. Drug Enforcement Administration, the U.S. Patent and Trademark Office, and the National Advertising Division of the Better Business Bureau.  While attending law school Mr. Pavel interned with the Illinois Attorney General's Office Health Care Bureau.

Professional Background

Prior to joining K&L Gates, Mr. Pavel was an associate in the Food and Drug and Health Care areas of a Washington, DC law firm.  Mr. Pavel is proficient in Hungarian.

Professional/Civic Activities

  • Chair Ex-Officio, Institute of Food Technologists, Food Laws and Regulations Division
  • Board of Directors, Center for Telemedicine and e-Health Law
  • Advisory Board, Cancer News on the Net, 2002 – present
  • American Bar Association
  • District of Columbia Bar Association
  • Maryland Bar Association

Speaking Engagements

  • “MidPack 2011 Conference McCormick Place Chicago Challenges for Industry; Devices, Pharma, & CPG,” September 20-22, 2011
  • “Center for Telehealth and e-Health Law Are You a Medical Device Manufacturer? The FDA’s Final Rule on MDDS,” August 15, 2011
  • “FDANews Supplier Quality Management Congress Auditing Your Entire Supplier Base Once A Year Benchmarks for Success,” August 10, 2011
  • “Ketchum Inc. – Worldwide Webinar Food Claims & Labeling Enforcement,” July 21, 2011
  • “IFT Annual Meeting Food Laws and Regulations,” June 13-15, 2011
  • “IFT Webinar FDA’s Menu Labeling Rule,” May 17, 2011
  • “Petfood Forum 2011 Food Safety Modernization Act: Implications for the Petfood Industry,” April 14, 2001
  • “IFT - Wellness 11, Functional Foods: US and EU Regulatory and Enforcement Update,” Chicago, March 23-24, 2011
  • “McGladrey Food Industry CFO Meeting Food Safety Modernization Act: Overview - Regulatory & Cost Implications,” April 20, 2011
  • “Center for Profession Advancement Medical Device Regulatory Compliance – 2011,” April 11-13, 2011
  •  “Federal Food Regulatory Conferences Food Claims & Labeling Enforcement Update,” April 5, 2011
  • “IFT Food Leadership Meeting,” Food Laws and Regulations, March 3-4, 2011
  • “PMMI – Though Leaders Meeting Food Safety Modernization Act: Overview,” March 1, 2011
  • “IFT Webinar,” Recent FTC, FDA Activity Related to Health Claims, February 16, 2011
  • “IFT Food Safety Legislation Forum,” Food GMPs v. 2010 – New Controls, Testing, and Other Requirements , January 7, 2011
  • “Overview and Trends in Allergen Labeling,” 21st Annual Federal Food Regulatory Conference, Prime Label Consultants, Washington, DC, April 2009
  • “Health Claims and Functional Foods – 2009 Update,” Institute of Food Technologists, Washington, DC, April 2009
  • “Functional Foods and Nutraceuticals – an Update on Regulations and the Patent Landscape,” Institute of Food Technologists, Chicago, IL, March 2009
  • “Trends and Opportunities in the Allergen-Free Market: Looking Ahead,” Institute of Food Technologists, Chicago, IL, March 2009
  • “IFT DC – Nutrition Legislative Update,” Institute of Food Technologists, Washington, DC, 2008
  • “Connecting with Large Healthcare Systems and Academic Centers,” ATA Annual Meeting, 2008
  • “Update – Voluntary Microwave Guidelines and Developments in Clones Meat Labeling,” Food Regulatory Conference, April 2008
  • “So the Food Is ‘Functional’ – But Is It Legal?,” Institute of Food Technologists, Chicago, IL, February 2008
  • “Congressional Update - Food Safety and Nutrition,” Institute of Food Technologists, Washington DC, January 2008
  • “Do's and Don'ts: Establishing Supplier Controls & Conducting Supplier Audits,” FOI Teleconferences, Washington DC, December 2007
  • “Medico-Legal Issues in Teleradiology: What You Need to Know,” Radiological Society of North America 93rd Scientific Assembly and Annual Meeting, Chicago, Il, November 2007
  • “Medical Device Regulatory Compliance,” three day conference for the Center for Professional Advancement (CFPA), Northbrook, IL, October 2004, New Brunswick, NJ, October 2007.
  • “Vendor and Contract Supplier Qualification,” three day conference for the Center for Professional Advancement (CFPA), Amsterdam, Holland, May 2006.
  • Speaker, “Documentation and Compliance: Keeping the OIG Away,” New Insights in Vascular Technology, 13th Annual Spring Conference, Michigan Heart & Vascular Institute, May 2004.
  • Principal lecturer, “CLIA Compliance Clinic: Strategies to Avoid Administrative Sanctions, Civil Monetary Penalties or Criminal Prosecution,” National Teleconference, The Coding Institute, September 2003.
  • “Hands on Telemedicine: Laws Requiring Physical Contact Prior to Electronic Practice,” American Telemedicine Association Annual Meeting, April 2003.