Expanded Access (Compassionate Use) Submission Data Archive
CBER and CDER Data through 2014
CBER and CDER Tables
- CBER and CDER Expanded Access INDs
- CBER and CDER Expanded Access Protocols
- CDER and CBER Totals for Expanded Access
CBER and CDER Expanded Access INDs
*** 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
*** 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 data ceased being compiled as of FY 2017.
*** 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.