U.S. flag An official website of the United States government
  1. Home
  2. News & Events
  3. Public Health Focus
  4. Expanded Access
  5. Expanded Access (Compassionate Use) Submission Data Archive: CDER and CBER
  1. Expanded Access

Expanded Access (Compassionate Use) Submission Data Archive: CDER and CBER

Expanded Access (Compassionate Use) Submission Data Archive: CDRH


CDER and CBER Archived Data (2010-2018)

CDER and CBER Tables

FY 2010 – 2018 Graphs of Expanded Access CDER and CBER Submissions

To view the graph select the appropriate link below.


CDER and CBER Tables

Expanded Access INDs for CDER and CBER (2010-2018)

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 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

FY 2014

CDER

696

692

1069

1066

52

50

0

0

 

CBER

22

19

45

44

1

1

1

1

FY 2013

CDER

550

550

315

313

28

27

0

0

 

CBER

37

31

112

112

10

8

0

0

FY 2012

CDER

289

287

14

14

0

0

1

1

 

CBER

47

39

36

35

1

1

2

2

10/13/2010 to 10/12/2011*

CDER

652

652

443

442

0

0

1

1

 

CBER

22

18

24

24

4

4

1

1

10/13/2009 to 10/12/2010*

CDER

484

484

516

500

2

2

0

0

 

CBER

17

14

24

24

1

1

0

0

* These reporting periods cover a one-year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.

** 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 (2010-2018)


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 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 2014

CDER

35

35

9

9

9

9

12

12

 

CBER

33

32

22

22

5

5

2

2

FY 2013

CDER

62

62

2

2

8

8

12

12

 

CBER

56

56

14

14

7

5

0

0

FY 2012

CDER

121

121

0

0

8

8

10

10

 

CBER

49

47

19

19

3

2

0

0

10/13/2010 to 10/12/2011*

CDER

89

89

3

3

1

1

11

11

 

CBER

36

36

6

6

4

4

1

1

10/13/2009 to 10/12/2010*

CDER

16

16

0

0

5

5

7

7

 

CBER

31

30

4

4

1

1

0

0

* These reporting periods cover a one-year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.


FY 2010 – 2018 Graphs of Expanded Access Submissions

CDER Expanded Access IND and Protocol Submissions (2010-2018)

CDER Expanded Access IND Submissions Fiscal Year 2010-2018

* These reporting periods cover a one-year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.

 

CDER Expanded Access Protocol Submissions Fiscal Year 2010-2018

* These reporting periods cover a one-year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.


CBER Expanded Access IND and Protocol Submissions (2010-2018)

CBER Expanded Access IND Submissions Fiscal Year 2010-2018

* These reporting periods cover a one-year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.

** 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.

CBER Expanded Access Protocol Submissions Fiscal Year 2010-2018

* These reporting periods cover a one-year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.


Combined CDER and CBER Expanded IND and Protocol Submissions (2010-2018)

CDER and CBER Expanded Access IND Submissions Fiscal Year 2010-2018

* These reporting periods cover a one-year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.

** 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.

CDER and CBER Expanded Access Protocol Submissions Fiscal Year 2010-2018

* These reporting periods cover a one-year cohort starting the day the Final Rule for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs went into effect. Starting with Fiscal Year 2012, the reporting period was changed to a fiscal year to match the reporting period for other IND activity reports.

** 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.

 
Back to Top