Lagarde, Lynne A

Mr. Tsien is a principal at OFW Law. He was born in New York City and received his B.S. Magna Cum Laude in chemistry and physics in 1971 from Tufts University, and his J.D. from the University of Washington School of Law in 1978.

Mr. Tsien served as Law Clerk to Chief Judge Frank D. James, Washington Court of Appeals, from 1978 to 1980.  He worked in the Office of Chief Counsel of the U.S. Food and Drug Administration from 1980 to 1985; at the time of his departure, he was Associate Chief Counsel for Veterinary Medicine and Enforcement.

Mr. Tsien joined the firm in 1986.  While his practice encompasses a broad range of FDA regulatory issues, the focus of his practice is matters affecting the generic drug industry.  He is the head of the firm's drug practice and litigation practice. Mr. Tsien and the firm have represented clients in Federal court cases involving FDA generic drug approval and exclusivity issues for over 20 different drug products.

Areas of Practice:

Food and Drug Law
Litigation

Bar Admissions:

Washington, 1978 (inactive status)
District of Columbia, 1987

Selected Court Admissions:

U.S. Supreme Court
U.S. Court of Appeals for the District of Columbia Circuit
U.S. Court of Appeals for the Federal Circuit
U.S. District Court for the District of Columbia

Special Agencies:

Food and Drug Administration
Department of Justice

Honors:

LMG Life Sciences Star, 2012
Washington, D.C. Super Lawyers, FDA Law, 2011 and 2012

Education:

University of Washington School of Law, Seattle, Washington, 1978
Juris Doctor

Tufts University, Medford, Massachusetts, 1971 Bachelor of Science
Honors: Magna Cum Laude, Phi Beta Kappa

Recent Representative Published Works:

Legal And Legislative Hurdles To Generic Drug Development, Approval, And Marketing, chapter in Generic Drug Product Development, Solid Oral Dosage Forms, Marcel Dekker, 2005.

Food And Drug Administration Modernization Act, chapter in The Pharmaceutical Regulatory Process, Marcel Dekker, 2005.

Legal And Legislative Hurdles To Generic Drug Development, Approval, And Marketing, chapter in Generic Drug Product Development, Solid Oral Dosage Forms, 2d Edition, informa healthcare, 2008.

American Bioscience, Inc. v. Thompson Rushing To Judgment In APA Litigation, FDLI Update, March/April 2002.