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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 03/07/14)

March 11, 2014

The CBER BTD #s are current as of 02/28/14 and the CDER BTD #s are current as of 03/07/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BT Requests received by the FDA increases from 149 to 159

•   The total # of FDA CDER + CBER BTs Granted by the FDA increases from 40 to 41

•   The total # of FDA CDER + CBER BTs Denied by the FDA increases from 80 to 87

•   The total # of FDA CDER + CBER BTs Pending by the FDA increases from 29 to 31.

FDA CBER + CDER BTDs as of 03/07/14

Breakthrough  Therapy (BT) Designation Category

Total #         of CBER Designations (07/09/12-02/28/14)

Total #         of CDER Designations (07/09/12-03/07/14)

Total # of CBER +   CDER BT   Designations (07/09/12-03/07/14)

Total # of BT Requests   Received

26

133

159

Total # of BTs Granted

1

40

41

Total # of BTs   Denied

19

68

87

Total # of BTs   Pending

6

25

31

 

OBSERVATIONS:

•   25.8 %    of the total # of BT Requests Received results in the BTD being granted

•   54.7 % 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.

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

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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