Follow-on Biologics Revisited: Who’s on First?

November 2, 2007 -- On September 27, President Bush signed into law a new FDA authorization bill which, according to the FDA, “represents a very significant addition to FDA authority.” But for the biotech industry, what was most significant was not the terms of the Act, but what was left out – the provision that would have given the FDA the authority to approve generic biotech drugs, or “follow-on biologics” (FOBs). More details...

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