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James Nicholas O'Neil Czaban

James Nicholas O'Neil Czaban

Practice areas:

Administrative Law, Life Sciences & Biotechnology, Health Care

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About Me

James Czaban is the Chair of the FDA Practice Group at Wiley Rein LLP in Washington, D.C.  Mr. Czaban has extensive experience in government regulation of pharmaceutical, biotechnology, food, medical device and healthcare related companies.  His practice focuses on counseling such clients on complex regulatory strategies and compliance matters, and representing clients in administrative and judicial enforcement actions and other proceedings involving the Food & Drug Administration (FDA), Federal Trade Commission (FTC), Drug Enforcement Administration (DEA), Department of Justice (DoJ) and other federal and state agencies.  Among his other awards, he has been recognized as a "Top Lawyer" in Food & Drug Law in every Washingtonian magazine ranking since 2004.

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Practice Areas

Licensed since 1995

  1. Life Sciences & Biotechnology: 40%
    23 years, 20 cases
  2. Administrative Law: 40%
    23 years, 20 cases
  3. Health Care: 20%
    23 years, 20 cases

Attorney Endorsements

1 total

  • John P Isacson Jr

    Jim is a superior lawyer in every sense. His knowledge of FDA and administrative practice is unparalled. Jim provides his clients with exemplary knowledge, keen legal instincts and a tireless work ethic.

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    John Isacson Patent Application Attorney
    Relationship: Fellow lawyer in community

Contact Info

Wiley Rein LLP

1776 K Street, NW
Washington, DC, 20006

Resume

License
StateStatusAcquiredUpdated
DCActive 199805/24/2015
NYCurrently registered 199503/13/2015

Professional Misconduct

We have not found any instances of professional misconduct for this lawyer.
Avvo Contributions
Legal Answers
Awards
Award NameGrantorDate Granted
Top Lawyer in Food & Drug LawWashingtonian Magazine2009
Nationally Ranked Practice Group -- FDA RegulatoryChambers and Partners2007
Life Sciences Practice Ranked in Cross-Border Super League N/A2007
Top Lawyer in Food & Drug LawWashingtonian Magazine2007
Top Lawyer, Food & Drug LawN/A2004

Associations
Association NamePosition NameDuration
Food and Drug Law InstituteAudit Committee Member2005 - Present
Food and Drug Law InstituteLegal Writing Awards Committee, Member and Chairman.2002 - Present
Professional organizations and associationsMember2001 - Present
District of Columbia BarAdmitted to Practice1998 - Present
Food and Drug Law InstituteLecturer1996 - Present
New York State Bar AssociationAdmitted to Practice1995 - Present
Virginia State BarAdmitted to Practice1992 - Present

Publications
Publication NameTitleDate
Treatise: Food and Drug Law and RegulationDrugs: INDs and Full NDAs2008
Specialty PharmaApproved Labeling Defense May Gain Traction in the Wake of FDA's Pre-Emption Declaration in Final Drug Labeling Rule2007
Winning Legal Strategies for Food & Drug Companies (Treatise)Being Compliant While Standing Your Ground2006
The Pharmaceutical Regulatory Process (Treatise)FDA Regulation of Biological Products2005
BNA's Pharmaceutical Law and Industry ReportMerck KGaA v. Integra Life Sciences: Supreme Court Applies Broad Interpretation of "Bolar Amendment" to Protect Innovative Drug Research From Claims of Patent Infringement2005
Specialty PharmaEmerging Regulatory Developments in Pharmacogenomics2005
Drug Delivery TechnologyOverstating FDA Regulatory Prospects Puts Stock at Risk2004
Building IP Value (Globe White Page, Pub.)Preserving and leveraging value from the IP/FDA interface2004
Legal TimesA Brand of Reform: New Medicare Law Attempts to Quell Tempest Over 180-Day Exclusivity2004
Fundamentals of Law and Regulation (Treatise)Human Drug Regulation1997

Education
School NameMajorDegreeGraduated
University of Virginia School of LawN/AJD1992
University of California - BerkeleyPolitical ScienceBA1988

Speaking Engagements
Conference NameTitleDate
Seton Hall Law School/NJIPLA -- Regulatory Developments for Pharmaceutical CompaniesThe Competitive Conundrum of "Authorized Generics"2007
RAPS Horizons ConferenceLifecycle Management Strategies For Drug and Biotechnology Companies2007
MPM Capital Annual Healthcare Conference10 Regulatory Mistakes Early Stage Biotech Companies Make and How to Avoid Them2007
BIO 2007 Annual MeetingRepositioning Old Drug Products for New Markets2007
BayBio 2007 Annual MeetingFollow-On Proteins -- Legislative and Regulatory Update2007
Silicon Valley Association of General Counsel 18th Annual All Hands MeetingFDA Update: New Developments, and Outlook for Change Under the Democrat Congress2006
Harvard University -- Second Annual FDA Regulatory and Compliance SymposiumDeciphering Section 505(b)(2) NDAs2006
FDLI's Fundamentals of Food & Drug RegulationFDA Regulation of Pharmaceuticals and Biologics2006
FDLI Annual Educational ConferenceDevelopments in Drug Safety Regulation2006
AIPLA Annual ConferenceFollow-On Biologics -- What Does The Future Hold?2006
Australian Natural Products Industry MeetingRegulation and Marketing of Natural Products In The United States2004
ABA Administrative Law ConferenceBalancing Innovation and Competition In the U.S. Pharmaceutical Market2003