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Expanded Access (compassionate use) submission data

CDER, CBER and CDRH Expanded Access INDs and Protocols (2014-2018)

On this page you will find:

  • The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) expanded access submission receipt reports for INDs and Protocols from 2014-2018
  • The Center for Devices and Radiological Health (CDRH) expanded access requests from 2014-2018

The reports are broken down to the following:

FY 2014 – 2018 (most recent 5 years) Graphs of Expanded Access Submissions

To view the graph select the appropriate link below.

For older graphs, see archive page.

Expanded Access INDs for CDER and CBER (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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CDRH Expanded Access Requests (2014-2018)

FY 2014-2018 (most recent 5 years) Graph of CDRH Expanded Access Requests

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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CDER Graph – IND Submissions

CDER Graph IND Submissions

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CDER Graph – IND Protocols

CDER Graph IND Protocols

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CBER Graph – IND Submissions

CBER Graph IND Submissions

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CBER Graph – IND Protocols

CBER Graph IND Protocols

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CBER/CDER Graph – IND Submissions

CBER/CDER Graph IND Protocols

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CBER/CDER Graph – IND Protocols

CBER/CDER Graph IND Protocols

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CDRH Graph

CDRH Graph

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