Congress appears poised this year to deliver on years of lobbying by industry to speed up reviews of new drugs and cut regulatory red tape. Chief among several related bills is the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Faster action on drug applications is the goal of the Faster Access to Specialized Treatments (FAST) Act introduced in the House of Representatives, the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act introduced in the Senate, and another Senate bill, the Advancing Breakthrough Therapies for Patients Act of 2012. The impact of these legislations would be seen in the Phase II and III stage and less so in the valley of death.

Poll Question:
How useful will bills to speed up drug approvals be on improving the investment climate?



Not Very


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