sábado, 23 de julio de 2016

Abbreviated New Drug Application (ANDA): Generics > Generic Drug Review Dashboard Report

Abbreviated New Drug Application (ANDA): Generics > Generic Drug Review Dashboard Report



The U.S. Food and Drug Administration’s Office of Generic Drugs (OGD) has posted its third quarterly update of the Generic Drug Review Dashboard Report.  This report includes current submission status for the total original abbreviated new drug application (ANDA) workload as well as review activities and communications tracking.  OGD is providing this update to improve transparency as we continue implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA), which is part of OGD’s comprehensive and ongoing efforts to make quality, affordable generic medicines available to the American public.



The Office of Generic Drugs (OGD) provides these updates to improve transparency and communication as we continue to implement the Generic Drug User Fee Amendments of 2012 (GDUFA). OGD’s implementation of GDUFA is part of our ongoing efforts to make quality, affordable generic medicines available to the American public.
 
These reports include the Current Submission Status Snapshot for:
  • Total Original ANDA Workload Activity for Pre-GDUFA Year 3 Application Cohorts (Figure 1)
  • Total Original ANDA Workload Activity for All Unapproved Applications (Figure 2)
 
These reports include the Activity and Review Communications Tracking for:
  • Original ANDAs - Total Agency Actions for the Most Recent 12 Months (Figure 3)
  • ANDA Prior Approval Supplements - Total Agency Actions for the Most Recent 12 Months (Figure 4)
 
This information is designed to provide industry and the public with clearer insight into the:
  • proportion of the ANDA workload that is pending review by FDA
  • proportion of the ANDA workload that is pending response by industry
  • ongoing review communications between FDA and industry

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