10.0
Superb
Overview
Practice Areas
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40% Administrative Law
16 years, 20 cases
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40% Life Sciences / Biotechnology
16 years, 20 cases
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20% Health Care
16 years, 20 cases
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Contact Information
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About Me
Photos (0)
Videos (0)
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About me: James Czaban is the Chairman of the FDA Department at WilmerHale. Mr. Czaban's practice focuses on providing legal, regulatory and legislative counseling to... more
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References
Client Reviews
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Endorsements
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Endorsement from lawyer:
John Isacson
, Washington (DC), 8 months ago
Relationship: Fellow lawyer in community
Endorsement:
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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Résumé
Licenses
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14 years
since James Nicholas O'Neil Czaban was first licensed to practice law in NY.
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10 years
since James Nicholas O'Neil Czaban was first licensed to practice law in DC.
We have not found any instances of professional misconduct for this lawyer.
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Work Experience
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| Position |
Duration |
| Shareholder at Heller Ehrman LLP |
2001–2006
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| Partner at Venable, LLP |
2001–2001
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| Associate at Venable, LLP |
1996–2000
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| Attorney at Bass & Ullman, P.C. |
1993–1996
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See all 4 job entries
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Education
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Awards
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| Award Name |
Granting Organization |
Date |
| FDA Practice Ranked in Regulatory Super League |
Practical Law Company (PLC) |
2007 |
| Life Sciences Practice Ranked in Cross-Border Super League |
Practical Law Company (PLC) |
2007 |
| Nationally Ranked Practice Group -- FDA Regulatory |
Chambers and Partners |
2007 |
| Top Lawyer, Food & Drug Law |
Washingtonian Magazine |
2004 |
See all 4 awards
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Associations
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| Position |
Association Name |
Duration |
| Admitted to Practice |
Virginia State Bar |
1992–present
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| Admitted to Practice |
New York State Bar Association |
1995–present
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| Lecturer |
Food and Drug Law Institute |
1996–present
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| Admitted to Practice |
District of Columbia Bar |
1998–present
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| Member |
Professional organizations and associations |
2001–present
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| Legal Writing Awards Committee, Member and Chairman. |
Food and Drug Law Institute |
2002–present
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| Audit Committee Member |
Food and Drug Law Institute |
2005–present
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See all 7 association entries
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Portfolio
Publications
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See all 9 publications
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Speaking Engagements
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| Speaking Engagement Name |
Conference |
Date |
| Repositioning Old Drug Products for New Markets |
BIO 2007 Annual Meeting |
2007 |
| Follow-On Proteins -- Legislative and Regulatory Update |
BayBio 2007 Annual Meeting |
2007 |
| 10 Regulatory Mistakes Early Stage Biotech Companies Make and How to Avoid Them |
MPM Capital Annual Healthcare Conference |
2007 |
| Lifecycle Management Strategies For Drug and Biotechnology Companies |
RAPS Horizons Conference |
2007 |
| The Competitive Conundrum of "Authorized Generics" |
Seton Hall Law School/NJIPLA -- Regulatory Developments for Pharmaceutical Companies |
2007 |
| Follow-On Biologics -- What Does The Future Hold? |
AIPLA Annual Conference |
2006 |
| Developments in Drug Safety Regulation |
FDLI Annual Educational Conference |
2006 |
| FDA Regulation of Pharmaceuticals and Biologics |
FDLI's Fundamentals of Food & Drug Regulation |
2006 |
| Deciphering Section 505(b)(2) NDAs |
Harvard University -- Second Annual FDA Regulatory and Compliance Symposium |
2006 |
| FDA Update: New Developments, and Outlook for Change Under the Democrat Congress |
Silicon Valley Association of General Counsel 18th Annual All Hands Meeting |
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 engagments
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