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Expanded Access (Compassionate Use) Submission Data

CDER, CBER and CDRH Expanded Access INDs and Protocols (2017-2021)

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 2017-2021
  • The Center for Devices and Radiological Health (CDRH) expanded access requests from 2017-2021

The reports are broken down to the following:

FY 2017 – 2021 (most recent 5 years) Graphs of Expanded Access Submissions

To view the graph select the appropriate link below.

For older graphs, see Expanded Access (Compassionate Use) Submission Data Archive: CDER and CBER and Expanded Access (Compassionate Use) Submission Data Archive: CDRH.

Expanded Access INDs for CDER and CBER (2017-2021)

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 2021 CDER 880 876 1040 1035 6 4 2 2
CBER 125 125 216 212 5 5 0 0
FY 2020 CDER 1034 1014 1779 1776 6 4 5 2
CBER 137 126 6292 6285 25 24 14 12
FY 2019 CDER 1083 1080 366 366 20 18 4 1
CBER 101 100 141 140 3 2 2 2
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

* In FY18, CBER received a large number of single patient expanded access submissions 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.

Expanded Access Protocols for CDER and CBER (2017-2021)

 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 2021 CDER 16 16 20 20 17 16 11 11
CBER 18 18 49 49 3 1 1 1
FY 2020 CDER 10 10 10 10 26 26 19 18
CBER 23 23 41 40 12 9 1 0
FY 2019 CDER 28 28 21 21 14 13 18 18
CBER 52 52 33 33 5 4 4 4
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 2017 – 2021 Graphs of Expanded Access Submissions

CDER Expanded Access INDs and Protocol (2017-2021)

CDER Expanded Access INDs and Protocol (2017-2021)
CDER Expanded Access Protocols (2017-2021)

CBER Expanded Access INDs and Protocols (2017-2021)

CBER Expanded Access INDs (2017-2021)
CBER Expanded Access Protocols (2017-2021)

Combined CDER and CBER Expanded Access Submissions and Protocols (2017-2021)

Combined CDER and CBER Expanded Access IND Submissions (2017-2021)
Combined CDER and CBER Expanded Access Protocol Submissions (2017-2021)

CDRH Expanded Access Requests (2017-2021)

FY 2017-2021 Graph of CDRH Expanded Access Requests

CDRH Expanded Access Requests 2017-2021

CDRH IDE Expanded Access Requests (2017-2021)

Expanded Access Totals FY 2017 FY 2018 FY 2019 FY 2020 FY 2021
Requested Received 100 79 76 92 106
Evaluable Requests 96 69 69 89 103
Approved 96 69 67 89 102
Percentage Approved 100.0% 100.0% 97.1% 100% 99.0%

CDRH Non-IDE Expanded Access Requests(2017-2021)1

Expanded Access Totals FY 2017 FY 2018 FY 2019 FY 2020 FY 2021
Requested Received 230 257 352 384 502
Evaluable Requests2 220 233 335 372 497
Approved 220 232 332 372 493
Percentage Approved3 100.0% 99.6% 99.1% 100% 99.2%

1 Expanded Access requests outside of an IDE are limited to single patient compassionate use requests.
2 Evaluable requests are requests in which a substantive review was performed on an original, non-IDE compassionate use request resulting in an approval or disapproval decision.
3 Based on approved requests to total number of evaluable requests.

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