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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 06/13/14)

June 23, 2014

The CBER BTD #s are current as of 05/31/14 and the CDER BTD #s are current as of 06/13/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 193 to 195

•   The total # of FDA CDER + CBER BTDs Granted by the FDA stays the same at 52

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 105 to 108

•   The total # of FDA CDER + CBER BTDs Pending by the FDA decreases from 36 to 35.

FDA CBER + CDER BTDs as of 06/13/14

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-05/31/14) Total # of CDER Designations (07/09/12-06/13/14) Total # of CBER +   CDER BTD Designations (07/09/12-06/13/14)
Total # of BTD Requests Received 31 164 195
Total # of BTDs Granted 4 48 52
Total # of BTDs   Denied 25 83 108
Total # of BTDs   Pending 2 33 35

.

OBSERVATIONS

•   26.7 %    of the total # of BTD Requests Received results in the BTD being granted

•   55.3 % of the total # of BTD Requests Received results in the BTD being denied

•   18.0 % of the total # of BTD 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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