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GEN Poll

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May 02, 2012

Quicker Development and Investing

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

Very
 
  27.5%
Somewhat
 
  37.5%
Not Very
 
  35.0%
Undecided
 
  0.0%

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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.

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Genome Sequencing and Patient Autonomy

Do you think ACMG’s recent recommendations for reporting incidental clinical sequencing results undermine patient autonomy?

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