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Expanded Access (Compassionate Use) Submission Data

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CDER, CBER and CDRH Expanded Access INDs and Protocols (2019-2023)

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 2019-2023
  • The Center for Devices and Radiological Health (CDRH) expanded access requests from 2019-2023

The reports are broken down to the following:

FY 2019 – 2023 (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 (2019-2023)

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 2023 CDER 1326 1318 634 634 18 16 1 1
CBER 192 173 136 136 2 0 2 1
FY 2022 CDER 1143 1133 789 789 27 25 7 7
CBER 181 166 283 265 5 4 1 1
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 1110 1080 425 423 20 18 3 2
CBER 101 100 141 140 3 2 2 2

Expanded Access Protocols for CDER and CBER (2019-2023)

 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 2023 CDER 12 12 0 0 19 18 12 11
CBER 19 18 23 23 2 1 0 0
FY 2022 CDER 25 25 8 8 16 16 10 10
CBER 28 26 29 29 6 4 0 0
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 2019 – 2023 Graphs of Expanded Access Submissions

CDER Expanded Access INDs and Protocol (2019-2023)

CDER Expanded Access IND Submissions for Fiscal Year 2019- 2023

 

CDER Expanded Access Protocol Submissions for Fiscal Year 2019-2023

 

CBER Expanded Access INDs and Protocols (2019-2023)

CBER Expanded Access IND Submissions Fiscal Year 2019-2023

 

CBER Expanded Access Protocol Submissions Fiscal Year 2019-2023

Combined CDER and CBER Expanded Access Submissions and Protocols (2019-2023)

CDER and CBER Expanded Access IND Submissions Fiscal Year 2019-2023

 

CDER and CBER Expanded Access Protocol Submissions Fiscal Year 2019-2023

 

CDRH Expanded Access Requests (2019-2023)

FY 2019-2023 Graph of CDRH Expanded Access Requests

CDRH Expanded Access Requests Fiscal Year 2019-2023

 

CDRH IDE Expanded Access Requests (2019-2023)1

Expanded Access Totals FY 2019 FY 2020 FY 2021 FY 2022 FY 2023
Requests Received 76 92 106 101 104
Evaluable Requests2 69 89 103 94 101
Approved 67 89 102 94 101
Percent Approved3 97.1% 100% 99.0% 100.0% 100.0%

1 Expanded Access IDE requests in CDRH reflect compassionate use (single patient or small population) requests.
2 Evaluable requests are decisions in which a substantive review was performed on an expanded access request (individual patient or small group access) resulting in an approval, approval with conditions, or disapproval decision.
3 Based on approved requests to total number of evaluable requests.

CDRH Non-IDE Expanded Access Requests(2019-2023)1

Expanded Access Totals FY 2019 FY 2020 FY 2021 FY 2022 FY 2023
Requests Received 352 384 502 587 741
Evaluable Requests2 335 372 497 580 732
Approved 332 372 493 578 722
Percent Approved3 99.1% 100% 99.2% 99.66% 98.63%

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/grant or disapproval/denial decision.
3 Based on approved/granted requests to total number of evaluable requests.

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