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                Prescription Drug User Fee Amendments

Prescription Drug User Fee Amendments Home
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          Prescription Drug User Fee Amendments
          PDUFA V: Fiscal Years 2013 - 2017Prescription Drug User Fee Amendments PDUFA V: Fiscal Years 2013 - 2017
  
  	
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    PrintOn July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. This new law includes the reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.

This is the fifth authorization of PDUFA that includes Title I of FDASIA and the performance goals and procedures for PDUFA V. As directed by Congress in the FDA Amendments Act of 2007, FDA developed the proposed enhancements for PDUFA V in consultation with drug industry representatives, patient and consumer advocates, health care professionals, and other public stakeholders from July 2010 through May 2011. FDA transmitted these proposed enhancements to Congress on January 13, 2012 which are referred to in Title I of FDASIA.

The new law ensures that FDA will continue to receive a source of stable and consistent funding during fiscal years 2013-2017 that will allow the agency to fulfill its mission to protect and promote public health by helping to bring to market critical new medicines for patients. This page contains the relevant information related to PDUFA V and FDA’s implementation of the PDUFA V enhancements.

PDUFA V Implementation

Assessment of Sentinel Systemâs Strengths, Limitations, and Appropriate Use
	PDUFA V Information Technology/Informatics Plan FY 2013 â FY 2017
	Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs
	Enhancing Benefit-Risk Assessment in Regulatory Decision-Making
	Enhanced Communication
	REMS Integration Initiative
	Enhancing Regulatory Science - Methodologies for Meta-AnalysisPDUFA V Reauthorization Information

PDUFA V Reauthorization Performance Goals and Procedures; Fiscal Years 2013 through 2017
	Prescription Drug User Fee Act; Notice of Public Meeting, October 24, 2011
	PDUFA V Meetings

                                                                                  Content current as of:
      09/15/2016Prescription Drug User Fee Amendments
 
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