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About James Nicholas
Biography
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.
Practice Areas
3
Practice Areas
Administrative Law
40%
34 years | 20 cases
Life Sciences and Biotechnology
40%
34 years | 20 cases
Health Care
20%
34 years | 20 cases
Fees and Rates
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Chat withLicenses
Licensed in District of Columbia for 27 years
State: District of Columbia
Acquired: 1998
No misconduct found
Licensed in New York for 31 years
State: New York
Acquired: 1995
No misconduct found
Location
Wiley Rein LLP
1776 K Street, NW, Washington, DC, 20006
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James Nicholas O'Neil Czaban's Reviews
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James Nicholas O'Neil Czaban's Lawyer Endorsements
John Isacson
Life sciences and biotechnology lawyer | Apr 17
Relationship: Fellow lawyer in community
"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. "
John Isacson
Patent application lawyer
Experience
Honors
2009
Top Lawyer in Food & Drug Law, Washingtonian Magazine
2007
Nationally Ranked Practice Group -- FDA Regulatory, Chambers and Partners
2007
Life Sciences Practice Ranked in Cross-Border Super League ,
2007
Top Lawyer in Food & Drug Law, Washingtonian Magazine
2004
Top Lawyer, Food & Drug Law,
Associations
2005 - Present
Food and Drug Law InstituteAudit Committee Member
2002 - Present
Food and Drug Law InstituteLegal Writing Awards Committee, Member and Chairman.
2001 - Present
Professional organizations and associationsMember
1998 - Present
District of Columbia BarAdmitted to Practice
1996 - Present
Food and Drug Law InstituteLecturer
1995 - Present
New York State Bar AssociationAdmitted to Practice
1992 - Present
Virginia State BarAdmitted to Practice
Education
1992
University of Virginia School of Law
JD
1988
University of California - Berkeley
BA
Speaking Engagements
2007
Seton Hall Law School/NJIPLA -- Regulatory Developments for Pharmaceutical Companies
The Competitive Conundrum of "Authorized Generics"
2007
RAPS Horizons Conference
Lifecycle Management Strategies For Drug and Biotechnology Companies
2007
MPM Capital Annual Healthcare Conference
10 Regulatory Mistakes Early Stage Biotech Companies Make and How to Avoid Them
2007
BIO 2007 Annual Meeting
Repositioning Old Drug Products for New Markets
2007
BayBio 2007 Annual Meeting
Follow-On Proteins -- Legislative and Regulatory Update
2006
Silicon Valley Association of General Counsel 18th Annual All Hands Meeting
FDA Update: New Developments, and Outlook for Change Under the Democrat Congress
2006
Harvard University -- Second Annual FDA Regulatory and Compliance Symposium
Deciphering Section 505(b)(2) NDAs
2006
FDLI's Fundamentals of Food & Drug Regulation
FDA Regulation of Pharmaceuticals and Biologics
2006
FDLI Annual Educational Conference
Developments in Drug Safety Regulation
2006
AIPLA Annual Conference
Follow-On Biologics -- What Does The Future Hold?
2004
Australian Natural Products Industry Meeting
Regulation and Marketing of Natural Products In The United States
2003
ABA Administrative Law Conference
Balancing Innovation and Competition In the U.S. Pharmaceutical Market
Publications
2008
Treatise: Food and Drug Law and Regulation
Drugs: INDs and Full NDAs
2007
2006
Winning Legal Strategies for Food & Drug Companies (Treatise)
Being Compliant While Standing Your Ground
2005
Specialty Pharma
Emerging Regulatory Developments in Pharmacogenomics
2005
BNA's Pharmaceutical Law and Industry Report
Merck KGaA v. Integra Life Sciences: Supreme Court Applies Broad Interpretation of "Bolar Amendment" to Protect Innovative Drug Research From Claims of Patent Infringement
2005
The Pharmaceutical Regulatory Process (Treatise)
FDA Regulation of Biological Products
2004
Legal Times
A Brand of Reform: New Medicare Law Attempts to Quell Tempest Over 180-Day Exclusivity
2004
Drug Delivery Technology
Overstating FDA Regulatory Prospects Puts Stock at Risk
2004
Building IP Value (Globe White Page, Pub.)
Preserving and leveraging value from the IP/FDA interface
1997
Fundamentals of Law and Regulation (Treatise)
Human Drug Regulation