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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 05/16/14)

May 27, 2014

The CBER BTD #s are current as of 04/30/14 and the CDER BTD #s are current as of 05/16/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BT Requests received by the FDA increases from 180 to 189

•   The total # of FDA CDER + CBER BTs Granted by the FDA increases from 46 to 50

•   The total # of FDA CDER + CBER BTs Denied by the FDA increases from 95 to 100

•   The total # of FDA CDER + CBER BTs Pending by the FDA remains at 39.

FDA CBER + CDER BTSs AS OF 05/16/14

Breakthrough  Therapy (BT) Designation Category Total # of CBER Designations (07/09/12-04/30/14) Total # of CDER Designations (07/09/12-05/16/14) Total # of CBER +   CDER BT   Designations (07/09/12-05/16/14)
Total # of BT Requests   Received 30 159 189
Total # of BTs Granted 4 46 50
Total # of BTs   Denied 23 77 100
Total # of BTs   Pending 3 36 39

.

OBSERVATIONS

•   26.5 %    of the total # of BT Requests Received results in the BTD being granted

•   53 % of the total # of BT Requests Received results in the BTD being denied

•   20.5 % 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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