Vaccines, Blood & Biologics

CBER Expanded Access Submission Receipt Reports

CBER Expanded Access Submission Receipt Reports
FY 2016 (October 1, 2015 - September 30, 2016)
Expanded Access INDs
Single Patient Emergency INDs received90
Single Patient Emergency INDs allowed to proceed90
Single Patient INDs received28
Single Patient INDs allowed to proceed27
Intermediate Size INDs received5
Intermediate Size INDs allowed to proceed5
Treatment INDs received4
Treatment INDs allowed to proceed2
Expanded Access Protocols
Single Patient Emergency Protocols received27
Single Patient Emergency Protocols allowed to proceed27
Single Patient Protocols received43
Single Patient Protocols allowed to proceed40
Intermediate Size Protocols received4
Intermediate Size Protocols allowed to proceed3
Treatment Protocols received2
Treatment Protocols allowed to proceed2
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER203
Total Number of Expanded Access INDs and Protocols allowed to proceed196
 
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 received68
Single Patient Emergency INDs allowed to proceed66
Single Patient INDs received32
Single Patient INDs allowed to proceed29
Intermediate Size INDs received2
Intermediate Size INDs allowed to proceed1
Treatment INDs received2
Treatment INDs allowed to proceed2
Expanded Access Protocols
Single Patient Emergency Protocols received13
Single Patient Emergency Protocols allowed to proceed13
Single Patient Protocols received48
Single Patient Protocols allowed to proceed47
Intermediate Size Protocols received1
Intermediate Size Protocols allowed to proceed0
Treatment Protocols received2
Treatment Protocols allowed to proceed2
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER168
Total Number of Expanded Access INDs and Protocols allowed to proceed160
 
CBER Expanded Access Submission Receipt Reports
FY 2014 (October 1, 2013 - September 30, 2014)
Expanded Access INDs
Single Patient Emergency INDs received45
Single Patient Emergency INDs allowed to proceed44
Single Patient INDs received22
Single Patient INDs allowed to proceed19
Intermediate Size INDs received1
Intermediate Size INDs allowed to proceed1
Treatment INDs received1
Treatment INDs allowed to proceed1
Expanded Access Protocols
Single Patient Emergency Protocols received22
Single Patient Emergency Protocols allowed to proceed22
Single Patient Protocols received33
Single Patient Protocols allowed to proceed32
Intermediate Size Protocols received5
Intermediate Size Protocols allowed to proceed5
Treatment Protocols received2
Treatment Protocols allowed to proceed2
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER131
Total Number of Expanded Access INDs and Protocols allowed to proceed126
 
CBER Expanded Access Submission Receipt Reports
FY 2013 (October 1, 2012 - September 30, 2013)
Expanded Access INDs
Single Patient Emergency INDs received112
Single Patient Emergency INDs allowed to proceed112
Single Patient INDs received37
Single Patient INDs allowed to proceed31
Intermediate Size INDs received10
Intermediate Size INDs allowed to proceed8
Treatment INDs received0
Treatment INDs allowed to proceed0
Expanded Access Protocols
Single Patient Emergency Protocols received14
Single Patient Emergency Protocols allowed to proceed14
Single Patient Protocols received56
Single Patient Protocols allowed to proceed56
Intermediate Size Protocols received7
Intermediate Size Protocols allowed to proceed5
Treatment Protocols received0
Treatment Protocols allowed to proceed0
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER236
Total Number of Expanded Access INDs and Protocols allowed to proceed226
 
CBER Expanded Access Submission Receipt Reports
FY 2012 (October 1, 2011 - September 30, 2012)
Expanded Access INDs
Single Patient Emergency INDs received36
Single Patient Emergency INDs allowed to proceed35
Single Patient INDs received47
Single Patient INDs allowed to proceed39
Intermediate Size INDs received1
Intermediate Size INDs allowed to proceed1
Treatment INDs received2
Treatment INDs allowed to proceed2
Expanded Access Protocols
Single Patient Emergency Protocols received19
Single Patient Emergency Protocols allowed to proceed19
Single Patient Protocols received49
Single Patient Protocols allowed to proceed47
Intermediate Size Protocols received3
Intermediate Size Protocols allowed to proceed2
Treatment Protocols received0
Treatment Protocols allowed to proceed0
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER157
Total Number of Expanded Access INDs and Protocols allowed to proceed145
 
CBER Expanded Access Submission Receipt Reports
RY 2011 (October 13, 2010 - October 12, 2011)
Expanded Access INDs
Single Patient Emergency INDs received24
Single Patient Emergency INDs allowed to proceed24
Single Patient INDs received22
Single Patient INDs allowed to proceed18
Intermediate Size INDs received4
Intermediate Size INDs allowed to proceed4
Treatment INDs received1
Treatment INDs allowed to proceed1
Expanded Access Protocols
Single Patient Emergency Protocols received6
Single Patient Emergency Protocols allowed to proceed6
Single Patient Protocols received38
Single Patient Protocols allowed to proceed36
Intermediate Size Protocols received4
Intermediate Size Protocols allowed to proceed3
Treatment Protocols received1
Treatment Protocols allowed to proceed1
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER100
Total Number of Expanded Access INDs and Protocols allowed to proceed93
 
CBER Expanded Access Submission Receipt Reports
RY 2010 (October 13, 2009 - October 12, 2010)
Expanded Access INDs
Single Patient Emergency INDs received24
Single Patient Emergency INDs allowed to proceed24
Single Patient INDs received17
Single Patient INDs allowed to proceed14
Intermediate Size INDs received1
Intermediate Size INDs allowed to proceed1
Treatment INDs received0
Treatment INDs allowed to proceed0
Expanded Access Protocols
Single Patient Emergency Protocols received4
Single Patient Emergency Protocols allowed to proceed4
Single Patient Protocols received31
Single Patient Protocols allowed to proceed30
Intermediate Size Protocols received1
Intermediate Size Protocols allowed to proceed1
Treatment Protocols received0
Treatment Protocols allowed to proceed0
Totals for Expanded Access
Total Number of Expanded Access INDs and Protocols received in CBER78
Total Number of Expanded Access INDs and Protocols allowed to proceed74
 

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