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Tapes Library

Branded/Generic Drug Policy: Fixing Hatch-Waxman - The Future of Market Exclusivity Extension
Speaker:
Steven Giuli, Director of Government Affairs, Generic Pharmaceutical Association
Date of Briefing:
June 14, 2002
Approximate length:
One hour
Description:
This session provides a short overview of the Hatch-Waxman Act, discussing the areas that are being considered for revisions and offer expert analysis on what ought to be done and the consequences of not making the correct fixes.
Price:
$195 Tape
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Tapes Library

Branded/Generic Drug Policy: Off-label Promotions -- Complying with FDA and SEC
Speaker:
Sam Kazman, General Counsel, Competitive Enterprise Institute
Date of Briefing:
June 12, 2002
Approximate length:
One hour
Description:
This session examines FDA's susceptibility to "deadly over-caution;" the long-term viability of Pediatric Rule reform; two studies on the speed of new drug approvals; the case against FDA's Pediatric Rule; and public sentiment toward the pharmaceutical industry.
Price:
$195 Tape
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