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                Expanded Access

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    PrintCDER, CBER and CDRH Expanded Access INDs and Protocols (2018-2022)

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 2018-2022
	The Center for Devices and Radiological Health (CDRH) expanded access requests from 2018-2022The reports are broken down to the following:

Expanded Access INDs (2018-2022)
	Expanded Access Protocols (2018-2022)FY 2018 – 2022 (most recent 5 years) Graphs of Expanded Access Submissions

To view the graph select the appropriate link below.

CDER Expanded Access INDs and Protocol (2018-2022)
	CBER Expanded Access INDs and Protocols (2018-2022)
	Combined CDER and CBER Expanded Access Submissions and Protocols (2018-2022)
	CDRH Expanded Access requests (2018-2022)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 (2018-2022)

Expanded Access INDs
			Individual (Single)
			Patient Non-Emergency
			IND
			Individual (Single) Patient
			Emergency IND
			Intermediate
			Size IND
			Treatment
			INDreceived
			allowed
			to proceed
			received
			allowed
			to proceed
			received
			allowed
			to proceed
			received
			allowed
			to proceedFY 2022
			CDER
			1143
			1133
			789
			789
			27
			25
			7
			7CBER
			181
			166
			283
			265
			5
			4
			1
			1FY 2021
			CDER
			880
			876
			1040
			1035
			6
			4
			2
			2CBER
			125
			125
			216
			212
			5
			5
			0
			0FY 2020
			CDER
			1034
			1014
			1779
			1776
			6
			4
			5
			2CBER
			137
			126
			6292
			6285
			25
			24
			14
			12FY 2019
			CDER
			1110
			1080
			425
			423
			20
			18
			3
			2CBER
			101
			100
			141
			140
			3
			2
			2
			2FY 2018
			CDER
			925
			922
			366
			366
			12
			11
			1
			1CBER
			123
			52*
			162
			162
			8
			7
			1
			1

* 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 (2018-2022)

Expanded Access Protocols
			Individual (Single)
			Patient Non-emergency
			Protocol
			Individual (Single) Patient
			Emergency Protocol
			Intermediate
			Size Protocol
			Treatment
			Protocolreceived
			allowed
			to proceed
			received
			allowed
			to proceed
			received
			allowed
			to proceed
			received
			allowed
			to proceedFY 2022
			CDER
			25
			25
			8
			8
			16
			16
			10
			10CBER
			28
			26
			29
			29
			6
			4
			0
			0FY 2021
			CDER
			16
			16
			20
			20
			17
			16
			11
			11CBER
			18
			18
			49
			49
			3
			1
			1
			1FY 2020
			CDER
			10
			10
			10
			10
			26
			26
			19
			18CBER
			23
			23
			41
			40
			12
			9
			1
			0FY 2019
			CDER
			28
			28
			21
			21
			14
			13
			18
			18CBER
			52
			52
			33
			33
			5
			4
			4
			4FY 2018
			CDER
			27
			27
			20
			20
			14
			14
			5
			5CBER
			27
			27
			28
			28
			5
			5
			3
			3

FY 2018 – 2022 Graphs of Expanded Access Submissions

CDER Expanded Access INDs and Protocol (2018-2022)

CDER Expanded Access IND Submissions Fiscal Year (FY) 2018 -2022


CDER Expanded Access Protocol Submissions Fiscal Year (FY) 2018 - 2022
CBER Expanded Access INDs and Protocols (2018-2022)

CBER Expanded Access IND Submissions Fiscal Year (FY) 2018 -2022


CBER Expanded Access Protocol Submissions Fiscal Year (FY) 2028 - 2022
Combined CDER and CBER Expanded Access Submissions and Protocols (2018-2022)

CDER and CBER Expanded Access IND Submissions Fiscal Year (FY) 2018 - 2022


CDER and CBER Expanded Access Protocol Submissions Fiscal Year (FY) 2018 - 2022


CDRH Expanded Access Requests (2018-2022)

FY 2018-2022 Graph of CDRH Expanded Access Requests

CDRH Expanded Access Requests Fiscal Year (FY) 2018 - 2022


CDRH IDE Expanded Access Requests (2018-2022)

Expanded Access Totals
			FY 2018
			FY 2019
			FY 2020
			FY 2021
			FY 2022Requested Received
			79
			76
			92
			106
			101Evaluable Requests
			69
			69
			89
			103
			94Approved
			69
			67
			89
			102
			94Percentage Approved
			100.0%
			97.1%
			100%
			99.0%
			100.0%

CDRH Non-IDE Expanded Access Requests(2018-2022)1

Expanded Access Totals
			FY 2018
			FY 2019
			FY 2020
			FY 2021
			FY 2022Requested Received
			257
			352
			384
			502
			587Evaluable Requests2
			233
			335
			372
			497
			580Approved
			232
			332
			372
			493
			578Percentage Approved3
			99.6%
			99.1%
			100%
			99.2%
			99.66%

1Expanded Access requests outside of an IDE are limited to single patient compassionate use requests.2Evaluable 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.3Based on approved requests to total number of evaluable requests.

                                                                                  Content current as of:
      05/17/2023
              
              
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