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)

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)

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

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

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.

Source