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FDA Breakthrough Therapy Designation: 1st CBER Granted And Statistics Updated (As of 12/06/13)

December 11, 2013

The first FDA CBER Breakthrough Therapy Designation (BTD) is granted per the latest numbers from the FDA website. The identification of the sponsor company that has received the 1st FDA CBER BTD as of 12/11/13 is not known yet. Per the FDA website:

“FDA will not disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designation. Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a).”   

CBER is the FDA’s Center for Biologics Evaluation and Research that regulates biological products for human use, such as allergenics, blood, devices, gene therapy, human tissues and cellular products, vaccines, and xenotransplantation products.

The 3 FDA BTDs that receive approval are from CDER.

FDA CBER + CDER BTDs as of 12/06/13

Breakthrough       Therapy (BT) Designation Category

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

Total     # of CDER Designations (07/09/12-12/06/13)

Total   #   of CBER + CDER BT   Designations (07/09/12-12/06/13)

Total       # of BT Requests Received

15

117

132

Total       # of BTs Granted

1

35

36

Total #     of   BTs Denied

12

56

68

Total       # of BTs Pending

2

26

28

 

CHANGES

•   The total # of FDA CDER + CBER BT Requests received by the FDA increases from 121 to 132

•   The total # of FDA CDER + CBER BTs Granted by the FDA increases from 34 to 36

•   The total # of FDA CDER + CBER BTs Denied by the FDA increases from 61 to 68

•   The total # of FDA CDER + CBER BTs Pending by the FDA increases from 26 to 28.

OBSERVATIONS

•   27.3 %    of the total # of BT Requests Received results in the BTD being granted

•   51.5 % of the total # of BT Requests Received results in the BTD being denied

•   21.2 % 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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2 Comments
  1. Anonymous permalink

    Thank you for the CDER/CBER division of the numbers, and for being a great resource for those of us in the rare disease community.

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