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• Figure 5: Decrease in FDA First Cycle Review Time for Abbreviated New Drug Applications, Fiscal Years 2013 through 2015

  • Uploaded by: U.S. Government Accountability Office
  • License: United States Government Work
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  • 3,303 views
  • Date uploaded: 2017-06-27
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, gao17452, genericdruguserfees, anda, abbreviatednewdrugapplication, cber, centerforbiologicsevaluationandresearch, cder, centerfordrugevaluationandresearch, fda, foodanddrugadministration, fy, fiscalyear, gdufa, genericdruguserfeeamendmentsof2012, hhs, departmentofhealthandhumanservices, hq, headquarters, it, informationtechnology, ogd, officeofgenericdrugs, ora, officeofregulatoryaffairs, pas, priorapprovalsupplement
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• Figure 6: Decrease in FDA First Cycle Review Time for Prior Approval Supplements, Fiscal Years 2013 through 2015

  • Uploaded by: U.S. Government Accountability Office
  • License: United States Government Work
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  • 3,197 views
  • Date uploaded: 2017-06-27
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, gao17452, genericdruguserfees, anda, abbreviatednewdrugapplication, cber, centerforbiologicsevaluationandresearch, cder, centerfordrugevaluationandresearch, fda, foodanddrugadministration, fy, fiscalyear, gdufa, genericdruguserfeeamendmentsof2012, hhs, departmentofhealthandhumanservices, hq, headquarters, it, informationtechnology, ogd, officeofgenericdrugs, ora, officeofregulatoryaffairs, pas, priorapprovalsupplement
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• Figure 1: Food and Drug Administration (FDA) Centers and Offices with Targeted Regulatory Science Projects Related to Medical Products, as of February 2016

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  • License: United States Government Work
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  • 2,022 views
  • Date uploaded: 2016-07-01
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, gao16432, medicalproductoversight, cber, centerforbiologicsevaluationandresearch, cder, centerfordrugevaluationandresearch, cdrh, centerfordevicesandradiologicalhealth, fda, foodanddrugadministration, fdasia, foodanddrugadministrationsafetyandinnovationactof2012, gdufa, genericdruguserfeeamendmentsof2012, gpra, governmentperformanceandresultsactof1993, hhs, departmentofhealthandhumanservices, nctr, nationalcenterfortoxicologicalresearch, ocet, officeofcounterterrorismandemergingthreats, oip, officeofinternationalprograms, omh, officeofminorityhealth, orsi, officeofregulatoryscienceandinnovation, owh, officeofwomenshealth, pdufa, prescriptiondruguserfeeact
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• Figure 1: Key Interactions and Stakeholders Involved in the Distribution of and Payment for Generic Drugs

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  • License: United States Government Work
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  • 1,796 views
  • Date uploaded: 2016-09-22
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, gao16706, genericdrugsundermedicare, anda, abbreviatednewdrugapplication, api, activepharmaceuticalingredient, cms, centersformedicaremedicaidservices, fda, foodanddrugadministration, ftc, federaltradecommission, gdufa, genericdruguserfeeamendmentsof2012, hhs, departmentofhealthandhumanservices, pbm, pharmacybenefitmanager, pde, prescriptiondrugevent
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• Figure 2: Price Trends under Medicare Part D for the Changing Basket and Established Basket of Generic Drugs, First Quarter 2010 through the Second Quarter 2015

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  • License: United States Government Work
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  • 1,748 views
  • Date uploaded: 2016-09-22
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, gao16706, genericdrugsundermedicare, anda, abbreviatednewdrugapplication, api, activepharmaceuticalingredient, cms, centersformedicaremedicaidservices, fda, foodanddrugadministration, ftc, federaltradecommission, gdufa, genericdruguserfeeamendmentsof2012, hhs, departmentofhealthandhumanservices, pbm, pharmacybenefitmanager, pde, prescriptiondrugevent
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