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Expanded Access (compassionate use) submission data

CDER, CBER and CDRH Expanded Access INDs and Protocols (2015-2019)

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 2015-2019
  • The Center for Devices and Radiological Health (CDRH) expanded access requests from 2015-2019

The reports are broken down to the following:

FY 2015 – 2019 (most recent 5 years) Graphs of Expanded Access Submissions

To view the graph select the appropriate link below.

For older graphs, see archive page.

Expanded Access INDs for CDER and CBER (2015-2019)

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 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
FY 2016 CDER 997 992 473 473 37 33 0 0
CBER 28 27 90 90 5 5 4 2
FY 2015 CDER 747 745 431 428 46 45 0 0
CBER 32 29 68 66 2 1 2 2

* A large number of the single patient expanded access submissions were 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.

For tables with older data, see archive page.

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Expanded Access Protocols for CDER and CBER (2015-2019)

 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 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 2016 CDER 16 16 6 6 6 6 10 10
CBER 43 40 27 27 4 3 2 2
FY 2015 CDER 14 14 7 7 9 9 8 8
CBER 48 47 13 13 1 0 2 2

FY 2015 – 2019 Graphs of Expanded Access Submissions

CDER Expanded Access INDs and Protocol (2015-2019)

CDER Expanded AccessIND Submissions FY15-19

 

CDER Expanded Access Protocol Submissions FY15-19

 

CBER Expanded Access INDs and Protocols (2015-2019)

CBER Expanded Access IND Submissions FY15-19
CBER Expanded Access Protocol Submissions FY15-19

 

Combined CDER and CBER Expanded Access Submissions and Protocols (2015-2019)

CBER and CDER Expanded Access IND Submissions FY15-19
CBER and CDER Expanded Access Protocol Submissions FY15-19

 

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CDRH Expanded Access Requests (2015-2019)

FY 2014-2018 Graph of CDRH Expanded Access Requests

CDRH Expanded Access Requests FY 15 - 19

CDRH IDE Expanded Access Requests (2015-2019)1

Expanded Access Totals
  FY 2015 FY 2016 FY 2017 FY 2018 FY 2019
Requested Received 222 136 100 79 76
Evaluable Requests2 211 124 96 69 69
Approved 210 123 96 69 67
Percentage Approved3 99.5% 99.2% 100.0% 100.0% 97.1%

1 1Expanded Access IDE requests in CDRH reflect compassionate use (single patient or small population) requests.
2 2Evaluable 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(2014-2018)1

Expanded Access Totals
  FY 2015 FY 2016 FY 2017 FY 2018 FY 2019
Requested Received 167 198 230 257 352
Evaluable Requests2 155 196 220 233 335
Approved 154 196 220 232 332
Percentage Approved3 99.4% 100.0% 100.0% 99.6% 99.1%

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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