Issue 2 : March/April 2003
Generic
Products:
Equivalents and Equivalence
March/April 2003
Subscription Information
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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.
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 GuidelinesImpact 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 MDUFMAReuse 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
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.)

