Congress moves toward reforming the FDA’s accelerated approvals
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WASHINGTON — Home lawmakers are shifting somewhat nearer towards cracking down on drugmakers that sport the FDA’s accelerated approval pathway, however their newest laws is friendlier to trade than earlier drafts.
The Home Vitality and Commerce Committee introduced Wednesday that its sweeping person payment authorization invoice will embody a revised coverage from Rep. Frank Pallone (D-N.J.) that may make it simpler for the Meals and Drug Administration to rescind its approval for medicine cleared by means of the pathway when drug makers don’t full required follow-up research.
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