U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. CBER Expanded Access Submission Receipt Reports
  1. Home

CBER Expanded Access Submission Receipt Reports

CBER Expanded Access Submission Receipt Reports

 
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 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 3
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