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New Senate bill would accelerate approval of breakthrough drugs

by Jeffrey Clark on April 25, 2012

Three Senators have introduced a bipartisan bill that would expedite the development and FDA approval of breakthrough drugs.

The Advancing Breakthrough Therapies for Patients Act would provide “the flexibility in approval mechanisms so home-run treatments that show great promise early on reach patients more quickly,” according to Senator Michael Bennet (D-CO).  The bill seeks a process to free the FDA to move faster when a drug or treatment shows dramatic responses early in development, while still ensuring drug safety and efficacy.  Specifically, the agency could push toward more innovative clinical trials with fewer patients and shorter timelines.

Pharmalot.com/Pharma Blog

 

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