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Expanded Access INDs and Protocols 2009 - 2016

On this page you will find Expanded Access Submission Receipt Reports 2009 - 2016. The reports are broken down to the following:

FY 2010 - 2016 Updated Graphs Expanded Access Submissions, . To view the graph select the appropriate link below.

Expanded Access INDs

 Expanded Access INDs
 
  Individual (Single)
Patient IND
 Individual (Single) Patient
Emergency INDs
  Intermediate
Size INDs
 Treatment
IND
 receivedallowed
to proceed
received allowed
to proceed
 receivedallowed
to proceed
 received allowed
to proceed
 10/13/2009 to 10/12/2010*** CDER 484 484 516 500 2 2 0 0
 CBER 17 14 24 24 1 1 0 0
 10/2010 to 10/2011***
 
 CDER 652 652 443 442 0 0 1 1
 CBER 22 18 24 24 4 4 1 1
 
 FY 2012
 CDER 498 496 289 287 14 14 0 0
 CBER 47 39 36 35 1 1 2 2
  
 FY 2013
 CDER 550 550 315 313 28 27 0 0
 CBER 37 31 112 112 10 8 0 0
 
 FY 2014
 CDER 696 692 1069 1066 52 50 0 0
 CBER 22 19 45 44 1 1 1 1
 
 FY 2015
 CDER 747 745 431 428 46 45 0 0
 CBER 32 29 68 66 2 1 2 2
 
 FY 2016
 CDER 999 994 472 472 37 33 1 1
 CBER282790905542

*** These reporting periods cover a one year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.

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Expanded Access Protocols

 Expanded Access Protocols
 
  Individual (Single)
Patient Protocols
 Individual (Single) Patient
Emergency Protocols
  Intermediate
Size Protocols
 Treatment
Protocols
 receivedallowed
to proceed
received allowed
to proceed
 receivedallowed
to proceed
 received allowed
to proceed
 10/13/2009 to 10/12/2010*** CDER1616005577
 CBER3130441100
 10/2010 to 10/2011***
 
 CDER898933111111
 CBER3836664411
 
 FY 2012
 CDER12112100881010
 CBER494719193200
  
 FY 2013
 CDER626222881212
 CBER565614147500
 
 FY 2014
 CDER3535 99991212
 CBER333222225522
 
 FY 2015
 CDER141477 998 8
 CBER48471313 1022
 
 FY 2016
 CDER16166613131010
 CBER434027274322

*** These reporting periods cover a one year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.

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CDER and CBER Totals for Expanded Access

Totals for Expanded Access   Total Number of Expanded Access INDs and Protocols received Total Number of Expanded Access INDs and Protocols allowed to proceed 
  10/13/2009 to 10/12/2010***CDER 1030 1014 
CBER78  74
 10/2010 to 10/2011***CDER1200 1199 
CBER100  93
 FY 2012CDER 940936 
CBER 157145 
 FY 2013CDER 977974 
CBER 236 226
 FY 2014CDER 18821873 
CBER 131 126
 FY 2015CDER 1262 1256
CBER 168160 
 FY 2016CDER 1554 1545
CBER 203196 

 

*** These reporting periods cover a one year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.

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Page Last Updated: 03/24/2017
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