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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 04/04/14)

April 6, 2014

Updated 04/07/14: For CDER 04/04/14 #s.

The CBER BTD #s are current as of 03/31/14 and the CDER BTD #s are current as of 04/04/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BT Requests received by the FDA increases from 159 to 172

•   The total # of FDA CDER + CBER BTs Granted by the FDA increases from 41 to 42

•   The total # of FDA CDER + CBER BTs Denied by the FDA increases from 87 to 90

•   The total # of FDA CDER + CBER BTs Pending by the FDA increases from 31 to 40.

FDA CBER + CDER BTDs as of 04/04/14

Breakthrough  Therapy (BT) Designation Category Total # of CBER Designations (07/09/12-03/31/14) Total # of CDER Designations (07/09/12-04/04/14) Total # of CBER +   CDER BT   Designations (07/09/12-04/04/14)
Total # of BT Requests   Received 28 144 172
Total # of BTs Granted 2 40 42
Total # of BTs   Denied 20 70 90
Total # of BTs   Pending 6 34 40

.

OBSERVATIONS:

•   There are now 2 CBER BTDs.

•   24.4 %    of the total # of BT Requests Received results in the BTD being granted

•   52.3 % of the total # of BT Requests Received results in the BTD being denied

•   23.3 % 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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