CBER Expanded Access Submission Receipt Reports

CBER Expanded Access Submission Receipt Reports
FY 2023 (October 1, 2022- September 30, 2023)

Expanded Access INDs
Single Patient Emergency INDs received	136
Single Patient Emergency INDs allowed to proceed	136
Single Patient INDs received	192
Single Patient INDs allowed to proceed	173
Intermediate Size INDs received	2
Intermediate Size INDs allowed to proceed	0
Treatment INDs received	2
Treatment INDs allowed to proceed	1
Expanded Access Protocols
Single Patient Emergency Protocols received	23
Single Patient Emergency Protocols allowed to proceed	23
Single Patient Protocols received	19
Single Patient Protocols allowed to proceed	18
Intermediate Size Protocols received	2
Intermediate Size Protocols allowed to proceed	1
Treatment Protocols received	0
Treatment Protocols allowed to proceed	0
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	376
Total Number of Expanded Access INDs and Protocols allowed to proceed	352

 

CBER Expanded Access Submission Receipt Reports
FY 2022 (October 1, 2021- September 30, 2022)

Expanded Access INDs
Single Patient Emergency INDs received	283
Single Patient Emergency INDs allowed to proceed	265
Single Patient INDs received	181
Single Patient INDs allowed to proceed	166
Intermediate Size INDs received	5
Intermediate Size INDs allowed to proceed	4
Treatment INDs received	1
Treatment INDs allowed to proceed	1
Expanded Access Protocols
Single Patient Emergency Protocols received	29
Single Patient Emergency Protocols allowed to proceed	29
Single Patient Protocols received	28
Single Patient Protocols allowed to proceed	26
Intermediate Size Protocols received	6
Intermediate Size Protocols allowed to proceed	4
Treatment Protocols received	0
Treatment Protocols allowed to proceed	0
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	533
Total Number of Expanded Access INDs and Protocols allowed to proceed	495

 

CBER Expanded Access Submission Receipt Reports
FY 2021 (October 1, 2020- September 30, 2021)

Expanded Access INDs
Single Patient Emergency INDs received	216
Single Patient Emergency INDs allowed to proceed	212
Single Patient INDs received	125
Single Patient INDs allowed to proceed	125
Intermediate Size INDs received	5
Intermediate Size INDs allowed to proceed	5
Treatment INDs received	0
Treatment INDs allowed to proceed	0
Expanded Access Protocols
Single Patient Emergency Protocols received	49
Single Patient Emergency Protocols allowed to proceed	49
Single Patient Protocols received	18
Single Patient Protocols allowed to proceed	18
Intermediate Size Protocols received	3
Intermediate Size Protocols allowed to proceed	1
Treatment Protocols received	1
Treatment Protocols allowed to proceed	1
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	417
Total Number of Expanded Access INDs and Protocols allowed to proceed	411

 

CBER Expanded Access Submission Receipt Reports
FY 2020 (October 1, 2019 - September 30, 2020)

Expanded Access INDs
Single Patient Emergency INDs received	6292
Single Patient Emergency INDs allowed to proceed	6285
Single Patient INDs received	137
Single Patient INDs allowed to proceed	126
Intermediate Size INDs received	25
Intermediate Size INDs allowed to proceed	24
Treatment INDs received	14
Treatment INDs allowed to proceed	12
Expanded Access Protocols
Single Patient Emergency Protocols received	41
Single Patient Emergency Protocols allowed to proceed	40
Single Patient Protocols received	23
Single Patient Protocols allowed to proceed	23
Intermediate Size Protocols received	12
Intermediate Size Protocols allowed to proceed	9
Treatment Protocols received	1
Treatment Protocols allowed to proceed	0
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	6545
Total Number of Expanded Access INDs and Protocols allowed to proceed	6519

 

CBER Expanded Access Submission Receipt Reports
FY 2019 (October 1, 2018 - September 30, 2019)

Expanded Access INDs
Single Patient Emergency INDs received	141
Single Patient Emergency INDs allowed to proceed	140
Single Patient INDs received	101
Single Patient INDs allowed to proceed	100
Intermediate Size INDs received	3
Intermediate Size INDs allowed to proceed	2
Treatment INDs received	2
Treatment INDs allowed to proceed	2
Expanded Access Protocols
Single Patient Emergency Protocols received	33
Single Patient Emergency Protocols allowed to proceed	33
Single Patient Protocols received	52
Single Patient Protocols allowed to proceed	52
Intermediate Size Protocols received	5
Intermediate Size Protocols allowed to proceed	4
Treatment Protocols received	4
Treatment Protocols allowed to proceed	4
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	341
Total Number of Expanded Access INDs and Protocols allowed to proceed	337

 

CBER Expanded Access Submission Receipt Reports
FY 2018 (October 1, 2017 - September 30, 2018)

Expanded Access INDs
Single Patient Emergency INDs received	162
Single Patient Emergency INDs allowed to proceed	162
Single Patient INDs received	123
Single Patient INDs allowed to proceed	52
Intermediate Size INDs received	8
Intermediate Size INDs allowed to proceed	7
Treatment INDs received	1
Treatment INDs allowed to proceed	1
Expanded Access Protocols
Single Patient Emergency Protocols received	28
Single Patient Emergency Protocols allowed to proceed	28
Single Patient Protocols received	27
Single Patient Protocols allowed to proceed	27
Intermediate Size Protocols received	5
Intermediate Size Protocols allowed to proceed	5
Treatment Protocols received	3
Treatment Protocols allowed to proceed	3
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	357
Total Number of Expanded Access INDs and Protocols allowed to proceed	285

 

CBER Expanded Access Submission Receipt Reports
FY 2017 (October 1, 2016 - September 30, 2017)

Expanded Access INDs
Single Patient Emergency INDs received	80
Single Patient Emergency INDs allowed to proceed	79
Single Patient INDs received	40
Single Patient INDs allowed to proceed	36
Intermediate Size INDs received	11
Intermediate Size INDs allowed to proceed	10
Treatment INDs received	2
Treatment INDs allowed to proceed	2
Expanded Access Protocols
Single Patient Emergency Protocols received	42
Single Patient Emergency Protocols allowed to proceed	42
Single Patient Protocols received	25
Single Patient Protocols allowed to proceed	25
Intermediate Size Protocols received	4
Intermediate Size Protocols allowed to proceed	4
Treatment Protocols received	1
Treatment Protocols allowed to proceed	1
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	205
Total Number of Expanded Access INDs and Protocols allowed to proceed	199

 

CBER Expanded Access Submission Receipt Reports
FY 2016 (October 1, 2015 - September 30, 2016)

Expanded Access INDs
Single Patient Emergency INDs received	90
Single Patient Emergency INDs allowed to proceed	90
Single Patient INDs received	28
Single Patient INDs allowed to proceed	27
Intermediate Size INDs received	5
Intermediate Size INDs allowed to proceed	5
Treatment INDs received	4
Treatment INDs allowed to proceed	2
Expanded Access Protocols
Single Patient Emergency Protocols received	27
Single Patient Emergency Protocols allowed to proceed	27
Single Patient Protocols received	43
Single Patient Protocols allowed to proceed	40
Intermediate Size Protocols received	4
Intermediate Size Protocols allowed to proceed	3
Treatment Protocols received	2
Treatment Protocols allowed to proceed	2
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	203
Total Number of Expanded Access INDs and Protocols allowed to proceed	196

 

CBER Expanded Access Submission Receipt Reports
FY 2015 (October 1, 2014 - September 30, 2015) ***data only up to 28Sept15

Expanded Access INDs
Single Patient Emergency INDs received	68
Single Patient Emergency INDs allowed to proceed	66
Single Patient INDs received	32
Single Patient INDs allowed to proceed	29
Intermediate Size INDs received	2
Intermediate Size INDs allowed to proceed	1
Treatment INDs received	2
Treatment INDs allowed to proceed	2
Expanded Access Protocols
Single Patient Emergency Protocols received	13
Single Patient Emergency Protocols allowed to proceed	13
Single Patient Protocols received	48
Single Patient Protocols allowed to proceed	47
Intermediate Size Protocols received	1
Intermediate Size Protocols allowed to proceed	0
Treatment Protocols received	2
Treatment Protocols allowed to proceed	2
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	168
Total Number of Expanded Access INDs and Protocols allowed to proceed	160

 

CBER Expanded Access Submission Receipt Reports
FY 2014 (October 1, 2013 - September 30, 2014)

Expanded Access INDs
Single Patient Emergency INDs received	45
Single Patient Emergency INDs allowed to proceed	44
Single Patient INDs received	22
Single Patient INDs allowed to proceed	19
Intermediate Size INDs received	1
Intermediate Size INDs allowed to proceed	1
Treatment INDs received	1
Treatment INDs allowed to proceed	1
Expanded Access Protocols
Single Patient Emergency Protocols received	22
Single Patient Emergency Protocols allowed to proceed	22
Single Patient Protocols received	33
Single Patient Protocols allowed to proceed	32
Intermediate Size Protocols received	5
Intermediate Size Protocols allowed to proceed	5
Treatment Protocols received	2
Treatment Protocols allowed to proceed	2
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	131
Total Number of Expanded Access INDs and Protocols allowed to proceed	126

 

CBER Expanded Access Submission Receipt Reports
FY 2013 (October 1, 2012 - September 30, 2013)

Expanded Access INDs
Single Patient Emergency INDs received	112
Single Patient Emergency INDs allowed to proceed	112
Single Patient INDs received	37
Single Patient INDs allowed to proceed	31
Intermediate Size INDs received	10
Intermediate Size INDs allowed to proceed	8
Treatment INDs received	0
Treatment INDs allowed to proceed	0
Expanded Access Protocols
Single Patient Emergency Protocols received	14
Single Patient Emergency Protocols allowed to proceed	14
Single Patient Protocols received	56
Single Patient Protocols allowed to proceed	56
Intermediate Size Protocols received	7
Intermediate Size Protocols allowed to proceed	5
Treatment Protocols received	0
Treatment Protocols allowed to proceed	0
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	236
Total Number of Expanded Access INDs and Protocols allowed to proceed	226

 

CBER Expanded Access Submission Receipt Reports
FY 2012 (October 1, 2011 - September 30, 2012)

Expanded Access INDs
Single Patient Emergency INDs received	36
Single Patient Emergency INDs allowed to proceed	35
Single Patient INDs received	47
Single Patient INDs allowed to proceed	39
Intermediate Size INDs received	1
Intermediate Size INDs allowed to proceed	1
Treatment INDs received	2
Treatment INDs allowed to proceed	2
Expanded Access Protocols
Single Patient Emergency Protocols received	19
Single Patient Emergency Protocols allowed to proceed	19
Single Patient Protocols received	49
Single Patient Protocols allowed to proceed	47
Intermediate Size Protocols received	3
Intermediate Size Protocols allowed to proceed	2
Treatment Protocols received	0
Treatment Protocols allowed to proceed	0
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	157
Total Number of Expanded Access INDs and Protocols allowed to proceed	145

 

CBER Expanded Access Submission Receipt Reports
RY 2011 (October 13, 2010 - October 12, 2011)

Expanded Access INDs
Single Patient Emergency INDs received	24
Single Patient Emergency INDs allowed to proceed	24
Single Patient INDs received	22
Single Patient INDs allowed to proceed	18
Intermediate Size INDs received	4
Intermediate Size INDs allowed to proceed	4
Treatment INDs received	1
Treatment INDs allowed to proceed	1
Expanded Access Protocols
Single Patient Emergency Protocols received	6
Single Patient Emergency Protocols allowed to proceed	6
Single Patient Protocols received	38
Single Patient Protocols allowed to proceed	36
Intermediate Size Protocols received	4
Intermediate Size Protocols allowed to proceed	4
Treatment Protocols received	1
Treatment Protocols allowed to proceed	1
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	100
Total Number of Expanded Access INDs and Protocols allowed to proceed	93

 

CBER Expanded Access Submission Receipt Reports
RY 2010 (October 13, 2009 - October 12, 2010)

Expanded Access INDs
Single Patient Emergency INDs received	24
Single Patient Emergency INDs allowed to proceed	24
Single Patient INDs received	17
Single Patient INDs allowed to proceed	14
Intermediate Size INDs received	1
Intermediate Size INDs allowed to proceed	1
Treatment INDs received	0
Treatment INDs allowed to proceed	0
Expanded Access Protocols
Single Patient Emergency Protocols received	4
Single Patient Emergency Protocols allowed to proceed	4
Single Patient Protocols received	31
Single Patient Protocols allowed to proceed	30
Intermediate Size Protocols received	1
Intermediate Size Protocols allowed to proceed	1
Treatment Protocols received	0
Treatment Protocols allowed to proceed	0
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER	78
Total Number of Expanded Access INDs and Protocols allowed to proceed	74