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News Feature
Nature Biotechnology 26, 15–18 (1 January 2008) | doi:10.1038/nbt0108-15
Biotech as Bush bows out
Abstract
Follow-on biologics, changes to the patent system, new rules from the FDA and the prospect of a new party in the White House dominate the policy outlook for biotechs. Aaron Lorenzo reports. As 2007 came to a close, the US biotech industry began absorbing the impact of new safety powers handed to the US Food and Drug Administration in the reform bill that passed at the eleventh hour last fall, the FDA Amendments Act (FDAAA, or PDUFA IV as it's known in the industry). The good news for drugmakers is that the latest regulatory powers don't appear as stringent as first thought.
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