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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 01/22/14)

January 22, 2014

The CBER BTD #s are current as of 12/31/13 & the CDER BTD #s are current as of 01/22/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BT Requests received by the FDA increases from 140 to 144

•   The total # of FDA CDER + CBER BTs Granted by the FDA remains at 37

•   The total # of FDA CDER + CBER BTs Denied by the FDA increases from 71 to 77

•   The total # of FDA CDER + CBER BTs Pending by the FDA decreases from 32 to 30.

FDA CBER + CDER BTDs as of 01/22/14

Breakthrough           Therapy (BT) Designation Category

Total     #     of CBER Designations (07/09/12-12/31/13)

Total     #     of CDER Designations (07/09/12-01/22/14)

Total   #       of CBER + CDER BT   Designations (07/09/12-01/22/14)

Total           # of BT Requests Received

20

124

144

Total           # of BTs Granted

1

36

37

Total #         of   BTs Denied

13

64

77

Total           # of BTs Pending

6

24

30

 

OBSERVATIONS:

•   25.7 %    of the total # of BT Requests Received results in the BTD being granted

•   53.5 % of the total # of BT Requests Received results in the BTD being denied

•   20.8 % 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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