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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 05/31/14)

June 10, 2014

The CBER BTD #s are current as of 05/31/14 and the CDER BTD #s are current as of 05/30/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 189 to 193

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 50 to 52

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 100 to 105

•   The total # of FDA CDER + CBER BTDs Pending by the FDA decreases from 39 to 36.

FDA CBER + CDER BTDs as of 05/31/14

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-05/31/14) Total # of CDER Designations (07/09/12-05/30/14) Total # of CBER +   CDER BTD Designations (07/09/12-05/31/14)
Total # of BTD Requests Received 31 162 193
Total # of BTDs Granted 4 48 52
Total # of BTDs   Denied 25 80 105
Total # of BTDs   Pending 2 34 36

.

OBSERVATIONS

•   26.9 %    of the total # of BTD Requests Received results in the BTD being granted

•   54.4 % of the total # of BTD Requests Received results in the BTD being denied

•   18.7 % 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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