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Expanded Access INDs and Protocols 2009 - 2015

Expanded Access Submission Receipt Reports 2009 - 2015

This Expanded Access information may also be viewed as graphs.


Expanded Access INDs

Expanded Access INDs 10/13/2009-
10/12/2010***
10/2010-
10/2011***
10/2011-
9/2012
10/2012-
9/2013
10/2013-
9/2014
10/2014-
9/2015
CDER CBER CDER CBER CDER CBER CDER CBER CDER CBER CDER CBER
Single Patient INDs received 484 17 652 22 498 47 550 37 696 22 747 32
Single Patient INDs allowed to proceed 484 14 652 18 496 39 550 31 692 19 745 29
Single Patient Emergency INDs received 516 24 443 24 289 36 315 112 1069 45 431 68
Single Patient Emergency INDs allowed to proceed 500 24 442 24 287 35 313 112 1066 44 428 66
Intermediate Size INDs received 2 1 0 4 14 1 28 10 52 1 46 2
Intermediate Size INDs allowed to proceed 2 1 0 4 14 1 27 8 50 1 45 1
Treatment INDs received 0 0 1 1 0 2 0 0 0 1 0 2
Treatment INDs allowed to proceed 0 0 1 1 0 2 0 0 0 1 0 2

Expanded Access Protocols

Expanded Access Protocols 10/13/2009-
10/12/2010***
10/13/2010-
10/12/2011***
10/1/2011-
9/30/2012
10/1/2012-
9/30/2013
10/1/2013-
9/30/2014
10/1/2014-
9/30/2015
CDER CBER CDER CBER CDER CBER CDER CBER CDER CBER CDER CBER
Single Patient Protocols received 16 31 89 38 121 49 62 56 35 33 14 48
Single Patient Protocols allowed to proceed 16 30 89 36 121 47 62 56 35 32 14 47
Single Patient Emergency Protocols received 0 4 3 6 0 19 2 14 9 22 7 13
Single Patient Emergency Protocols allowed to proceed 0 4 3 6 0 19 2 14 9 22 7 13
Intermediate Size Protocols received 5 1 1 4 8 3 8 7 9 5 9 1
Intermediate Size Protocols allowed to proceed 5 1 1 4 8 2 8 5 9 5 9 0
Treatment Protocols received 7 0 11 1 10 0 12 0 12 2 8 2
Treatment Protocols allowed to proceed 7 0 11 1 10 0 12 0 12 2 8 2

Totals for Expanded Access

Totals for Expanded Access 10/13/2009-
10/12/2010***
10/13/2010-
10/12/2011***
10/1/2011-
9/30/2012
10/1/2012-
9/30/2013
10/1/2013-
9/30/2014
10/1/2014-
9/30/2015
Total Number of Expanded Access INDs and Protocols received in CDER 1030 1200 940 977 1882 1262
Total Number of Expanded Access INDs and Protocols allowed to proceed 1014 1199 936 974 1873 1256

*** 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.

Page Last Updated: 02/23/2016
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