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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 12/20/13)

December 26, 2013

The CBER BTD #s are current as of 11/30/13 & the CDER BTD #s are current as of 12/20/13.

The changes are as follows:

•   The total # of FDA CDER + CBER BT Requests received by the FDA increases from 132 to 135

•   The total # of FDA CDER + CBER BTs Granted by the FDA increases from 36 to 37

•   The total # of FDA CDER + CBER BTs Denied by the FDA increases from 68 to 70

•   The total # of FDA CDER + CBER BTs Pending by the FDA remains at 28.

FDA CBER + CDER BTDs as of 12/20/13

Breakthrough       Therapy (BT) Designation Category

Total     # of CBER Designations (07/09/12-11/30/13)

Total     # of CDER Designations (07/09/12-12/20/13)

Total   #   of CBER + CDER BT   Designations (07/09/12-12/20/13)

Total       # of BT Requests Received

15

120

135

Total       # of BTs Granted

1

36

37

Total #     of   BTs Denied

12

58

70

Total       # of BTs Pending

2

26

28

 

OBSERVATIONS:

•   27.4 %    of the total # of BT Requests Received results in the BTD being granted

•   52 % of the total # of BT Requests Received results in the BTD being denied

•   20.6 % 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 © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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