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Mr. Gibbs has represented health care companies on FDA-related matters since 1984. He advises companies on a wide variety of issues, including product approvals, marketing, clinical studies, and enforcement. Previously, he served in the Chief Counsel's Office of the U.S. Food and Drug Administration, where he became an Associate Chief Counsel for Enforcement. While at FDA, Mr. Gibbs received the FDA Award of Merit. He also was appointed a Special Assistant United States Attorney for the District of Columbia. Before joining FDA, he clerked for a United States District Court Judge in the District of New Jersey. Mr. Gibbs has written and lectured extensively on a variety of FDA-related topics. Mr. Gibbs served as a member of the Editorial Advisory Board for the Food and Drug Law Journal from 1998 to 2004, and was Chair in 2003-2004. He is currently on the editorial advisory board of IVD Technology and Guide to Good Clinical Practices, and is a member of the Human Subjects Research Board for George Mason University. Mr. Gibbs serves as Secretary and General Counsel of the Board of Directors of the Food and Drug Law Institute. He is a graduate of Princeton University (1975 summa cum laude) and the New York University School of Law (1978 with honors). He is admitted to practice law in the District of Columbia.
Articles / Publications
15th Anniversary Essay: Regulation Then and Now,
August 2010
The Problem of Regulatory Uncertainty,
July 2010
Regulatory Pathways for Clearance or Approval of IVDs,
May 2010
Oversight of Research Use Only Products,
March 1, 2010
In Vitro Diagnostic Tests for Cancer: Regulation of Laboratory Developed Tests,
January 2010
The Custom Device Exemption: What Is It And Does It Ever Apply?,
September 2009
Banked-Specimen Retrospective Studies,
June 15, 2009
Making the Most of Pre-IDE Meetings,
March 1, 2009
Taking control of the IVD submission process,
January 2009
Adroit Crafting of "Intended Use" Critical - Regulatory Fate of a New IVD May Well Depend on a Few Dozen Words,
November 15, 2008
Personalized Medicine - Panacea or Pipedream?,
September 2008
Lessons Learned from the AbTox Ruling,
September 2008
Regulatory Pathways for Molecular Dx - Detailing the Various Options Available and What Each Requires,
August 1, 2008
Primer on Regulation of Diagnostic Assays - Essential Points that Pharmaceutical Companies Need to Know Right Now,
July 1, 2008
FDA's Regulatory Extensions: An Overburdened Agency Assigns Itself New Responsibilities,
June 13, 2008
FDA's latest ASR guidance document creates more confusion and raises legal issues,
April 2008
Court case determines specimen ownership,
January 2008
Clinical Trial Participation Unaffected by Disclosure of Investigator's Financial Stake,
December 18, 2007
FDA Releases Final Guidance on ASRs,
September 14, 2007
FDA Issues Second Draft Version of IVDMIA Guidance,
July 25, 2007
Jeff Gibbs Cited as FDA Law Authority by Federal Appeals Court,
May 2007
Questions over FDA's Authority to Regulate Laboratory Developed Tests,
March 2007
ASRs and IVDMIAs: FDA's New Draft Guidances,
March 2007
Abigail Alliance v. von Eschenbach.,
March 2, 2007
State of the Union: Drug-Device Combinations,
November 2006
Sponsor of Clinical Drug Trial Not Required to Continue Providing Drug to Participants After Termination of the Study,
May 2006
Health and Speech Rights at Risk from Attacks on Medical Education,
April 12, 2006
It's The Law: Disgorgement and Restitution,
February 2006
What You Don't Know about AIP Can Hurt You,
November 2005
Just Sign on the Dotted Line?,
June 20, 2005
Exploring other options, Part 2: Facilitating the FDA review process,
June 2005
Exploring other options, Part 1: The trend toward alternative market pathways,
May 2005
FDA Must Reform Its Arbitrary Drug Name Review Process,
January 28, 2005
State Regulation of Pharmaceutical Clinical Trials,
2004
Western States Medical Center: A Watershed Moment for FDA's Regulation of Commercial Speech,
January/February 2003
Can FDA Seek Restitution or Disgorgement?,
2003
Ripe for Revision: Reassessing the Contitutionality of Food and Drug Administration Restriction on Protected Speech,
2003
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