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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

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  • 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

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  • 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 1: The 10 Countries with the Most Foreign Drug Establishments Manufacturing Drugs for the U.S. Market as of June 2021

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  • License: United States Government Work
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  • 1,128 views
  • Date uploaded: 2022-02-17
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, drugsafety, gao22103611, api, activepharmaceuticalingredient, cder, centerfordrugevaluationandresearch, cgmp, currentgoodmanufacturingpractices, conops, conceptofoperations, covid19, coronavirusdisease2019, facts, fieldaccomplishmentsandcompliancetrackingsystem, fda, foodanddrugadministration, fdasia, foodanddrugadministrationsafetyandinnovationact, gdufa, genericdruguserfeeact, gs, generalschedule, hhs, departmentofhealthandhumanservices, nai, noactionindicated, oai, officialactionindicated, ogps, officeofglobalpolicyandstrategy, opm, officeofpersonnelmanagement, ora, officeofregulatoryaffairs, vai, voluntaryactionindicated
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• Figure 5: Comparison of potential centralized and distributed manufacturing models

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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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• 3D printing of drugs, an example of advanced manufacturing

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  • License: United States Government Work
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  • 939 views
  • Date uploaded: 2023-03-16
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, gao23105650, drugmanufacturing, aspr, administrationforstrategicpreparednessandresponse, cder, centerfordrugevaluationandresearch, etp, emergingtechnologyprogram, fda, foodanddrugadministration, frame, frameworkforregulatoryadvancedmanufacturingevaluation, hhs, departmentofhealthandhumanservices, nist, nationalinstituteofstandardsandtechnology
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• FDA Drug Investigator Vacancies, November 2021–June 2024

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  • 498 views
  • Date uploaded: 2024-11-25
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, drugsafety, gao25106775, cder, centerfordrugevaluationandresearch, fda, foodanddrugadministration, gmp, goodmanufacturingpractices, hhs, departmentofhealthandhumanservices, ora, officeofregulatoryaffairs
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• Figure 1: Number of Establishments in the U.S. and the 10 Countries with the Most Foreign Drug Establishments Manufacturing Drugs for the U.S. Market, as of January 2024

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  • 488 views
  • Date uploaded: 2024-11-25
  • Tags: gao, governmentaccountabilityoffice, usgovernmentaccountabilityoffice, usgao, unitedstatesgovernmentaccountabilityoffice, government, congress, watchdog, oversight, governmentwatchdog, drugsafety, gao25106775, cder, centerfordrugevaluationandresearch, fda, foodanddrugadministration, gmp, goodmanufacturingpractices, hhs, departmentofhealthandhumanservices, ora, officeofregulatoryaffairs
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