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Biologics
Avoiding No Man's Land: New Deloitte Study on Follow-on Biologics Investigates Proposed Legislation and Possible Unintended Consequences
May 2nd, 2009
Deloitte released a study, Avoiding no man's land: Potential unintended consequences of follow-on biologics, that explores the debate on creating a regulatory pathway for the approval of follow-on biologics (FOBs), drugs that are envisioned as the biotech equivalent of generic pharmaceuticals. The study examines two bills that have recently been introduced in Congress, both based on the model of the Hatch-Waxman Act of 1984. The Deloitte study also outlines unintended effects of the Hatch-Waxman legislation and explores how this experience may help guide current legislation. "At the crux of the argument is how opening a regulatory pathway for FOBs can be accomplished...
Source: Law & Health Weekly (2009-05-02)
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