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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 12/31/13)

January 5, 2014

The CBER BTD #s are current as of 12/31/13 & 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 135 to 140

•   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 70 to 71

•   The total # of FDA CDER + CBER BTs Pending by the FDA increases from 28 to 32.

FDA CBER + CDER BTDs as of 12/31/13

Breakthrough         Therapy (BT) Designation Category

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

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

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

Total         # of BT Requests Received

20

120

140

Total         # of BTs Granted

1

36

37

Total #       of   BTs Denied

13

58

71

Total         # of BTs Pending

6

26

32

 

OBSERVATIONS:

•   26.4 %    of the total # of BT Requests Received results in the BTD being granted

•   50.7 % of the total # of BT Requests Received results in the BTD being denied

•   22.9 % 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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4 Comments
  1. Albert Giovenella permalink

    Thank you so much, Ann.
    Albert

  2. Albert Giovenella permalink

    Is there a list of the few breakthrough therapies from 2012?

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