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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 01/31/14)

February 9, 2014

Both the CBER BTD #s and the CDER BTD #s are current as of 01/31/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BT Requests received by the FDA increases from 144 to 149

•   The total # of FDA CDER + CBER BTs Granted by the FDA increases from 37 to 40

•   The total # of FDA CDER + CBER BTs Denied by the FDA increases from 77 to 80

•   The total # of FDA CDER + CBER BTs Pending by the FDA decreases from 30 to 29.

 

FDA CBER + CDER BTDs as of 01/31/14

Breakthrough             Therapy (BT) Designation Category

Total     #       of CBER Designations (07/09/12-01/31/14)

Total     #       of CDER Designations (07/09/12-01/31/14)

Total   #         of CBER + CDER BT   Designations (07/09/12-01/31/14)

Total             # of BT Requests Received

22

127

149

Total             # of BTs Granted

1

39

40

Total #           of   BTs Denied

16

64

80

Total             # of BTs Pending

5

24

29

 

OBSERVATIONS:

•   26.8 %    of the total # of BT Requests Received results in the BTD being granted

•   53.7 % of the total # of BT Requests Received results in the BTD being denied

•   19.5 % of the total # of BT Requests Received results in the BTD pending.

LINKS FOR FDA BTD #s:

•   The latest “FDA CDER + CBER Breakthrough Therapy Designation Statistics Chart” will always be located at URL http://wp.me/p2w211-1tA, so please bookmark

•   The latest “FDA Breakthrough Therapy Designation Approval Chart”, will always be located at URL http://wp.me/p2w211-1LD, so please bookmark

•   The latest “FDA Breakthrough Therapy Designation Chart” Blog Post will always be located at URL http://wp.me/p2w211-1mO, so please bookmark.

Please Note:Pascal Triangle Animated” by Hersfold on the English Wikipedia (Template:Bill) [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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