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Issue 2 : March/April 2003

 

Update 2003, Issue 2: Generic Products: Equivalents and Equivalence

 

 

Generic Products:
Equivalents and Equivalence

March/April 2003

Subscription Information
FDLI members receive Update as part of membership.
Additional copies or back issues are available at $15 each.

 

 

Feature Articles


Generic Drug Strategic Alliances: Competitive Opportunities and Antitrust Risks

by David A. Balto, Partner in the Worldwide Antitrust Practice Group of White & Case LLP, Washington, D.C. He is the former Director of the Policy Office of the Bureau of Competition, Federal Trade Commission.

Liability for Generic Drug Products: Issues to Consider
by Jill B. Deal, Of Counsel in the FDA Practice Group of the law firm of Venable, Baetjer, Howard & Civiletti, LLP, Washington, D.C.
Stephen E. Marshall, Partner in the Product Liability Group of the law firm of Venable, Baetjer, Howard & Civiletti, LLP, Washington, D.C.
and Stacia J. Borrello, Associate in the FDA Practice Group of the law firm of Venable, Baetjer, Howard & Civiletti, LLP, Washington, D.C.

Discovering Generic Drugs in Patent File Histories
by Kristin E. Behrendt, Associate at the law firm of Darby & Darby, P.C.,
New York, NY

"Fixing" Hatch-Waxman
by Richard J. Berman , Member of the law firm of Arent Fox Kintner Plotkin & Kahn PLLC, Washington, D.C.

The Right Tool for the Job: Closing Hatch-Waxman Act Loopholes Requires Legislative Reform
by Michael H. Hinckle, Attorney with the law firm of Kirkpatrick & Lockhart LLP, Washington, D.C.

Legislative Proposals to Change the Hatch-Waxman Act: Misguided and Unnecessary
by Bruce Kuhlik, Senior Vice President and General Counsel at Pharmaceutical Research and Manufacturers of America, Washington, D.C.
and Richard Smith, Senior Vice President for Policy and Research at Pharmaceutical Research and Manufacturers of America, Washington, D.C.

 

Also In This Issue


Key Asian Medical Regulatory Issues

by Ames Gross, President of Pacific Bridge, Inc., Washington, D.C.
and Caroline Tran, Senior Associate of Pacific Bridge, Inc., Washington, D.C.

New CME Guidelines—Impact on Drug and Device Companies
by John T. Bentivoglio, Partner with the law firm of Arnold & Porter, Washington, D.C.
and David Korn, Special Counsel with the law firm of Arnold & Porter,
Washington, D.C.

Title III of MDUFMA—Reuse Provisions: Strategic Opportunities for Industry
by John R. Manthei, Member of the FDA Practice Group in the law office of Latham & Watkins, Washington, D.C., and former Majority Counsel to the House Energy and Commerce Committee and Carolyne R. Hathaway, Member of the FDA Practice Group in the law office of Latham & Watkins, Washington, D.C.

Free Speech Visits the FDA
by Bruce Fein, a founding Partner in the law firm of Fein & Fein, Washington, D.C., and a former Associate Deputy Attorney General and General Counsel of the Federal Communications Commission

 

Columns


Making History

Wiley/Ringland Property in Historic Somerset District Is Renovated
by Suzanne White Junod, Ph.D., Historian with the Food and Drug Administration, Rockville, MD

Enforcement Corner
The Potential for Substantial Criminal Sentences Has Increased Again
by Steven M. Kowal, Partner in the law firm of Bell, Boyd & Lloyd, Chicago, IL

Global Corner
A Strategic Approach to Generic Drugs
by Matthew Weinberg, Chief Executive Officer of THE WEINBERG GROUP INC., Washington, D.C.

Associates' Corner
The Rise (and Possibly Fall) of Consumer Protection Class Actions
by Thomas Kane, Associate in the law firm of Dechert LLP, Princeton, NJ

Note: All author affiliations are current as of the date of publication of the issue.

 

 

(Note: All author affiliations are current as of the date of publication of the issue.)

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