Expanded Access (Compassionate Use) Submission Data
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.
- CDER Expanded Access INDs and Protocol (2019-2023)
- CBER Expanded Access INDs and Protocols (2019-2023)
- Combined CDER and CBER Expanded Access Submissions and Protocols (2019-2023)
- CDRH Expanded Access requests (2019-2023)
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)
CBER Expanded Access INDs and Protocols (2019-2023)
Combined CDER and CBER Expanded Access Submissions and Protocols (2019-2023)
CDRH Expanded Access Requests (2019-2023)
FY 2019-2023 Graph of CDRH Expanded Access Requests
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.