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 |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.