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  5. Expanded Access (Compassionate Use) Submission Data Archive FY 14 - 18
  1. Expanded Access

Expanded Access (Compassionate Use) Submission Data Archive FY 14 - 18

CDER and CBER Archived Data (2014-2018)

CDRH Expanded Access Requests (2014-2018)

CDER and CBER Archived Data (2014-2018)

CBER and CDER Tables

FY 2014 – 2018 Graphs of Expanded Access CDER and CBER Submissions

To view the graph select the appropriate link below.

CBER and CDER Tables

CBER and CDER Expanded Access INDs (2014-2018)

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
FY 2018 CDER 925 922 366 366 12 11 1 1
CBER 123 52* 162 162 8 7 1 1
FY 2017 CDER 1111 1107 461 461 36 35 0 0
CBER 40 36 80 70 11 10 2 2
FY 2016 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

* A large number of the single patient expanded access submissions were for non-emergency use of the same product, for which FDA determined the risks associated with its use would be unreasonable for the patients involved or there was insufficient information to make a determination. Excluding these submissions, 91% of CBER’s non-emergency single patient expanded access submissions received were allowed to proceed.

For tables with older data, see archive page.

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Expanded Access Protocols for CDER and CBER (2014-2018)

 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 2018 CDER 27 27 20 20 14 14 5 5
CBER 27 27 28 28 5 5 3 3
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

For tables with older data, see archive page.

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FY 2014 – 2018 Graphs of Expanded Access CDER and CBER Submissions

2014-2018 CBER Expanded Access INDs and Protocols (2014-2018)

CBER Expanded Access IND Submissions FY14-18

 

CBER Expanded Access Protocol Submissions FY14-18

2014-2018 CDER Expanded Access INDs and Protocol (2014-2018)

CDER Expanded Access IND Submissions FY114 -18

 

CDER Expanded Access Protocol Submissions FY14-18

2014-2018 Combined CDER and CBER Expanded Access Submissions and Protocols (2014-2018)

CBER and CDER Expanded Access IND Submissions FY14-18

 

CBER and CDER Expanded Access Protocol Submissions FY14-18

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CDRH Expanded Access Requests (2014-2018)

FY 2014-2018 Graph of CDRH Expanded Access Requests

CDRH Expanded Access Requests FY 14 - 18

CDRH IDE Expanded Access Requests (2014-2018)1

Expanded Access Totals
  FY 2014 FY 2015 FY 2016 FY 2017 FY 2018
Requested Received 218 222 136 100 79
Evaluable Requests2 212 211 124 96 69
Approved 211 210 123 96 69
Percentage Approved3 99.5% 99.5% 99.2% 100.0% 99.6%

1 Expanded Access IDE requests reflect compassionate use (single patient or small population) request supplements to existing IDEs. The Treatment IDE option is generally not used, and Emergency Use may proceed without prior FDA approval.
2 Evaluable requests are those sufficiently complete for FDA’s review and resulted in a decision to approve or deny.
3 Based on approved requests to total number of evaluable requests.

CDRH Non-IDE Expanded Access Requests(2014-2018)1

Expanded Access Totals
  FY 2014 FY 2015 FY 2016 FY 2017 FY 2018
Requested Received 179 167 198 230 257
Evaluable Requests2 167 155 196 220 233
Approved 165 154 196 220 232
Percentage Approved3 98.8% 99.4% 100.0% 100.0% 99.6%

1 Expanded Access requests outside of an IDE are limited to single patient compassionate use requests.
2 Evaluable requests are those sufficiently complete for FDA’s review and resulted in a decision to approve or deny.
3 Based on approved requests to total number of evaluable requests.

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