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  1. Expanded Access

Expanded Access (Compassionate Use) Submission Data Archive

Graphs

FY 2010 - 2017 Graphs of Expanded Access Submissions

To view the graph select the appropriate link below.

Tables

CBER and CDER Expanded Access INDs

FY 2013 CDER 550 550 315 313 28 27 0 0
CBER 31 112 112 10 8 0 0
FY 2012 CDER 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.

CBER and CDER Expanded Access Protocols

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.

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 1881 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.