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Expanded Access INDs and Protocols 2009 - 2017

On this page you will find Expanded Access Submission Receipt Reports for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) 2009 - 2017.

The reports are broken down to the following:

FY 2010 - 2017 Updated Graphs Expanded Access Submissions

To view the graph select the appropriate link below.

Expanded Access INDs

 Expanded Access INDs
 
  Individual (Single)
Patient Non-Emergency
IND
 Individual (Single) Patient
Emergency IND
  Intermediate
Size IND
 Treatment
IND
 received allowed
to proceed
received  allowed
to proceed
 received allowed
to proceed
 received  allowed
to proceed
FY2017  CDER 1111 1107 461 461 36 35  0  0
 CBER 40 36 80 79 11 10 2 2
FY2016  CDER 997 992 473 473 37 33 0 0
 CBER 28 27 90 90 5 5 4 2
 
 FY 2015
 CDER  747  745  431  428  46  45  0  0
 CBER  32  29  68  66  2  1  2  2
 
 FY 2014
 CDER  696  692  1069  1066  52  50  0  0
 CBER  22  19  45  44  1  1  1  1
  
 FY 2013
 CDER  550  550  315  313  28  27  0  0
 CBER  37  31  112  112  10  8  0  0
 
 FY 2012
 CDER  498  496  289  287  14  14  0  0
 CBER  47  39  36  35  1  1  2  2
 10/2010 to 10/2011***
 
 CDER  652  652  443  442  0  0  1  1
 CBER  22  18  24  24  4  4  1  1
 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

*** 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 Non-emergency
Protocol
 Individual (Single) Patient
Emergency Protocol
  Intermediate
Size Protocol
 Treatment
Protocol
 received allowed
to proceed
received  allowed
to proceed
 received allowed
to proceed
 received  allowed
to proceed
 FY 2017  CDER 14 14 4 4 4 4 7 7
 CBER 25 25 42 42 4 4 1 1
 FY 2016  CDER 16 16 6 6 6 6 10 10
 CBER 43 40 27 27 4 3 2 2
 
  FY 2015
 CDER 14 14 7 7 9 9 8 8
 CBER 48 47 13 13 1 0 2 2
 
 FY 2014
 CDER 35 35  9 9 9 9 12 12
 CBER 33 32 22 22 5 5 2 2
 
 FY 2013
 CDER 62 62 2 2 8 8 12 12
 CBER 56 56 14 14 7 5 0 0
 
 FY 2012
 CDER 121 121 0 0 8 8 10 10
 CBER 49 47 19 19 3 2 0 0
 
 10/2010 to 10/2011***
 CDER 89 89 3 3 1 1 11 11
 CBER 36 36 6 6 4 4 1 1
 10/13/2009 to 10/12/2010***  CDER 16 16 0 0 5 5 7 7
 CBER 31 30 4 4 1 1 0 0

*** 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 
 FY 2017 CDER  1637 1632
CBER 205 199
 FY 2016 CDER 1545 1536
CBER 203 196
 FY 2015  CDER 1262 1256
CBER 168 160
 FY 2014 CDER  1882 1873 
CBER  131  126
 FY 2013 CDER 977 974
CBER 236 226
 FY 2012 CDER 940 936
CBER 157 145
10/2010 to 10/2011*** CDER 1200 1199
CBER 100 93
  10/13/2009 to 10/12/2010*** CDER  1030  1014 
CBER 78   74

 

*** 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: 02/21/2018
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