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• Figure 2: Number of Cures Act Employees at FDA by Occupation, October 2021

  • Uploaded by: U.S. Government Accountability Office
  • License: United States Government Work
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  • 8,667 views
  • Date uploaded: 2022-01-31
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, fdaworkforce, gao22104791, cder, centerfordrugevaluationandresearch, cber, centerforbiologicsevaluationandresearch, cdrh, centerfordevicesandradiologicalhealth, fda, foodanddrugadministration, gs, generalschedule, hhs, departmentofhealthandhumanservices, ohcm, officeofhumancapitalmanagement, opm, officeofpersonnelmanagement, ots, officeoftalentsolutions, curesact
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• Figure 1: Food and Drug Administration’s (FDA) Typical Drug Development and Approval Process

  • Uploaded by: U.S. Government Accountability Office
  • License: United States Government Work
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  • 6,778 views
  • Date uploaded: 2017-07-19
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, gao17564, investigationalnewdrugs, bla, biologicslicenseapplication, cber, centerforbiologicsevaluationandresearch, cder, centerfordrugevaluationandresearch, compac, compassionateuseadvisorycommittee, fda, foodanddrugadministration, ind, investigationalnewdrugapplication, irb, institutionalreviewboard, nda, newdrugapplication, nyu, newyorkuniversity
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• Figure 5: Decrease in FDA First Cycle Review Time for Abbreviated New Drug Applications, Fiscal Years 2013 through 2015

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  • 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 2: Total Number of Food and Drug Administration (FDA) Medical Product Center Employees, Fiscal Years 2012 to 2015

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  • License: United States Government Work
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  • 2,010 views
  • Date uploaded: 2016-07-01
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, gao16500, foodanddrugadministration, bsufa, biosimilaruserfeeact, cber, centerforbiologicsevaluationandresearch, cder, centerfordrugevaluationandresearch, cdrh, centerfordevicesandradiologicalhealth, fda, fdasia, foodanddrugadministrationsafetyandinnovationactof2012, gdufa, genericdruguserfeeamendmentsact, gpra, governmentperformanceandresultsactof1993, hhs, departmentofhealthandhumanservices, mdufa, medicaldeviceuserfeeandmodernizationact, pdufa, prescriptiondruguserfeeactof1992, simp, strategicintegratedmanagementplan
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• Figure 5: Comparison of potential centralized and distributed manufacturing models

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  • License: United States Government Work
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  • 1,070 views
  • Date uploaded: 2023-11-03
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, gao23105430, regenerativemedicine, amd, agerelatedmaculardegeneration, cartcell, chimericantigenreceptortcell, cqa, criticalqualityattribute, cber, centerforbiologicsevaluationandresearch, cder, centerfordrugevaluationandresearch, cdrh, centerfordevicesandradiologicalhealth, fda, foodanddrugadministration, nist, nationalinstituteofstandardsandtechnology, rmat, regenerativemedicineadvancedtherapy, scb, standardscoordinatingbodyforgenecellandregenerativemedicinesandcellbaseddrugdiscovery
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• Figure 3: Examples of Funding Sources for the Department of Health and Human Services (HHS) Pandemic Public Health Preparedness and Response Systems

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  • License: United States Government Work
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  • 547 views
  • Date uploaded: 2024-09-26
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, covid19, gao24106638, aspr, administrationforstrategicpreparednessandresponse, ato, authorizationtooperate, dcipher, datacollationandintegrationforpublichealtheventresponse, cber, centerforbiologicsevaluationandresearch, cdc, centersfordiseasecontrolandprevention, cio, chiefinformationofficer, cis, caseisolatesurveillance, covidnet, covid19associatedhospitalizationsurveillancenetwork, crrsa, coronavirusresponseandreliefsupplementalappropriationsact, dmi, datamodernizationinitiative, fda, foodanddrugadministration, fitara, federalinformationtechnologyacquisitionreformact, fte, fulltimeequivalent, hhs, departmentofhealthandhumanservices, hiv, humanimmunodeficiencyvirus, hrsa, healthresourcesandservicesadministration, ihs, indianhealthservice, it, informationtechnology, nih, nationalinstitutesofhealth, nist, nationalinstituteofstandardsandtechnology, oes, outbreakeventsurveillance, omb, officeofmanagementandbudget, om, operationsandmaintenance, pdufa, prescriptiondruguserfeeact, pia, privacyimpactassessment, pii, personallyidentifiableinformation, saop, senioragencyofficialforprivacy, sorn, systemofrecordsnotice
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