US legislation for FDA approval of follow-on biologics: competing bipartisan proposals
The debate in the US Congress over the approval of follow-on biotechnology drugs has become more complicated by the presence of competing bills presented to the House of Representatives. First to be introduced were proposals by Rep Henry Waxman (Democrat, California), the Chairman of the House Energy and Commerce Committee who was also one of the architects of the Hatch-Waxman Act of 1984 which established the current system for generic drug reviews (Marketletters passim).
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