Following Europe's lead, the US Senate is now seriously considering a new FDA approval pathway that would allow for conditional, 2-year approvals for promising rare disease treatments. The new pathway would potentially pull ineffective drugs from the market more quickly than the current accelerated approval pathway does, but it also may open the door for more ineffective treatments relying on flimsy data. Read more below, and send us your thoughts: Does the US need a provisional approval pathway now for new rare disease treatments?
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Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
Media, page-546
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