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Overview
Practice Areas
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40% Administrative Law
20 years, 20 cases
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40% Life Sciences / Biotechnology
20 years, 20 cases
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20% Health Care
20 years, 20 cases
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Contact Information
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About Me
Photos (0)
Videos (0)
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James Czaban is the Chair of the FDA Practice Groupat Wiley Rein LLP in Washington, D.C. Mr. Czaban has extensive experience in government regulation of... more
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References
Client Reviews
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Peer Endorsements
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Jim is a superior lawyer in every sense. His knowledge of FDA and administrative practice is unparalled. Jim provides his clients with exemplary...
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Endorsement from lawyer:
John Isacson
, Washington (DC), Almost 4 years ago
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Résumé
License
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17 years since James Nicholas O'Neil Czaban was first licensed to practice law.
| State |
License status |
Year acquired |
Last updated by Avvo |
| New York |
Due to reregister within 30 days of birthday
|
1995 |
05/21/2011 |
| Dist. of Columbia |
Active
|
1998 |
09/12/2009 |
We have not found any instances of professional misconduct for this lawyer.
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Education
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| School |
Major |
Degree |
Graduated |
| University of Virginia School of Law |
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JD |
1992 |
| University of California - Berkeley |
Political Science |
BA |
1988 |
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Awards
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| Award Name |
Granting Organization |
Date |
| Top Lawyer in Food & Drug Law |
Washingtonian Magazine |
2009 |
| Nationally Ranked Practice Group -- FDA Regulatory |
Chambers and Partners |
2007 |
| Life Sciences Practice Ranked in Cross-Border Super League |
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2007 |
| Top Lawyer in Food & Drug Law |
Washingtonian Magazine |
2007 |
| Top Lawyer, Food & Drug Law |
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2004 |
See all 5 awards
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Associations
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| Position |
Association Name |
Duration |
| Audit Committee Member |
Food and Drug Law Institute |
2005-present
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| Legal Writing Awards Committee, Member and Chairman. |
Food and Drug Law Institute |
2002-present
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| Member |
Professional organizations and associations |
2001-present
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| Admitted to Practice |
District of Columbia Bar |
1998-present
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| Lecturer |
Food and Drug Law Institute |
1996-present
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| Admitted to Practice |
New York State Bar Association |
1995-present
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| Admitted to Practice |
Virginia State Bar |
1992-present
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See all 7 association entries
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Portfolio
Publications
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| Being Compliant While Standing Your Ground |
Winning Legal Strategies for Food & Drug Companies (Treatise) |
2006 |
| FDA Regulation of Biological Products |
The Pharmaceutical Regulatory Process (Treatise) |
2005 |
| Merck KGaA v. Integra Life Sciences: Supreme Court Applies Broad Interpretation of "Bolar Amendment" to Protect Innovative Drug Research From Claims of Patent Infringement |
BNA's Pharmaceutical Law and Industry Report |
2005 |
| Emerging Regulatory Developments in Pharmacogenomics |
Specialty Pharma |
2005 |
| Overstating FDA Regulatory Prospects Puts Stock at Risk |
Drug Delivery Technology |
2004 |
| Preserving and leveraging value from the IP/FDA interface |
Building IP Value (Globe White Page, Pub.) |
2004 |
| A Brand of Reform: New Medicare Law Attempts to Quell Tempest Over 180-Day Exclusivity |
Legal Times |
2004 |
| Human Drug Regulation |
Fundamentals of Law and Regulation (Treatise) |
1997 |
See all 10 publications
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Speaking Engagements
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| Presentation Name |
Conference |
Date |
| The Competitive Conundrum of "Authorized Generics" |
Seton Hall Law School/NJIPLA -- Regulatory Developments for Pharmaceutical Companies |
2007 |
| Lifecycle Management Strategies For Drug and Biotechnology Companies |
RAPS Horizons Conference |
2007 |
| 10 Regulatory Mistakes Early Stage Biotech Companies Make and How to Avoid Them |
MPM Capital Annual Healthcare Conference |
2007 |
| Repositioning Old Drug Products for New Markets |
BIO 2007 Annual Meeting |
2007 |
| Follow-On Proteins -- Legislative and Regulatory Update |
BayBio 2007 Annual Meeting |
2007 |
| FDA Update: New Developments, and Outlook for Change Under the Democrat Congress |
Silicon Valley Association of General Counsel 18th Annual All Hands Meeting |
2006 |
| Deciphering Section 505(b)(2) NDAs |
Harvard University -- Second Annual FDA Regulatory and Compliance Symposium |
2006 |
| FDA Regulation of Pharmaceuticals and Biologics |
FDLI's Fundamentals of Food & Drug Regulation |
2006 |
| Developments in Drug Safety Regulation |
FDLI Annual Educational Conference |
2006 |
| Follow-On Biologics -- What Does The Future Hold? |
AIPLA Annual Conference |
2006 |
| Regulation and Marketing of Natural Products In The United States |
Australian Natural Products Industry Meeting |
2004 |
| Balancing Innovation and Competition In the U.S. Pharmaceutical Market |
ABA Administrative Law Conference |
2003 |
See all 12 speaking engagements
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