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Regulatory and Government Affairs

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Litigation

Post-Grant

Prosecution & Counseling

Regulatory Law

Fish helps navigate the labyrinth of government regulations that accompany representation before administrative and regulatory agencies in both US and foreign markets.

We work with clients to achieve and maintain market access for their goods, to limit potential exposure to liability, to maximize business opportunities, and to help manage crisis situations. Our team has advanced technical expertise and extensive knowledge of the industries in which our clients operate.

Our regulatory attorneys have experience practicing before a wide range of federal agencies, including the following:

  • Federal Communications Commission (FCC)
  • National Telecommunications and Information Administration (NTIA)
  • Food and Drug Administration (FDA)
  • Department of State/Directorate of Defense Trade Controls (DDTC)
  • Department of Commerce/Bureau of Industry and Security (BIS)
  • Department of the Treasury/Office of Foreign Assets Control (OFAC)
  • Department of Transportation/Federal Aviation Administration (FAA)
  • National Aeronautics and Space Administration (NASA)
  • National Oceanic and Atmospheric Administration (NOAA)
  • Department of Defense (DOD)
  • Department of Homeland Security (DHS)/US Customs and Border Protection (CBP)
  • Federal Trade Commission (FTC)
  • Consumer Product Safety Commission (CPSC)
  • Department of Labor/Occupational Safety and Health Administration (OSHA)

International Technology Regulation
Our team advises clients on government regulatory programs that impact technology products and services in more than 75 countries. We have extensive experience in the fields of technology law, product standards, and regulation, and our attorneys are active members of many of the national and international organizations that make and enforce standards.Our worldwide contacts, including notifying bodies and clinical experts, help us to provide outstanding service regarding product compliance and market introduction. We also advise on compliance issues associated with domestic EMC, electrical safety, radiation safety, environmental, and medical device standards.

 

 


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Regulatory and Government Affairs

Regulatory and Government Affairs Team

What's Trending in Regulatory and Government Affairs

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Event
April 10th, 2016 | 11:15 am EDT
Pharma & Biotech Patents: A Hatch-Waxman & BPCIA (Biosimilars) Immersion Course Encompassing Prosecution Strategies, FDA Regulation, Post-Grant Challenge, and Litigation
Pharma & Biotech Patents: A Hatch-Waxman & BPCIA (Biosimilars) Immersion Course Encompassing Prosecution Strategies, FDA Regulation, Post-Grant Challenge, and Litigation
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January 19, 2016
Fish & Richardson Elevates 14 Attorneys to Principal
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December 7, 2015
Will the Trans-Pacific Partnership Derail Biologics?
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December 2, 2015
Patent Infringement at the ITC: Implications for Brand-Name Drug Companies
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November 12, 2015
Fish's Keith Barritt Quoted in Bloomberg BNA Medical Devices Law & Industry Report "FDA Data Show International Efforts; China Tops List of Foreign Inspection Sites"
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September 16, 2015
The Data Breach Nightmare
Author: Matthew Colvin
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August 10, 2015
FCC Releases Notice of Proposed Rulemaking on Approval Procedures for Radiofrequency Devices
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July 23, 2015
How To Avoid FDA Regulation Of Your Mobile Medical App
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July 8, 2015
Terry Mahn Quoted in Law360's "Medical Device Co. Pushes FCC For Ultra-Wideband Waiver"
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March 9, 2015
FDA Approves First Biosimilar Drug for US
Authors: Sara Koblitz, Terry G. Mahn
Life Sciences
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March 9, 2015
FDA Approves First Biosimilar Drug for U.S.
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February 18, 2015
Privacy Concerns for Individuals When State Governments Release Data
Authors: Sara Koblitz, Ed Lavergne, CIPP/US, Donna A. Balaguer, CIPP/US
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