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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 07/25/14)

July 30, 2014

The CBER BTD #s are current as of 06/30/14 and the CDER BTD #s are current as of 07/25/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 201 to 206

•   The total # of FDA CDER + CBER BTDs Granted by the FDA remains the same at 56

•   The total # of FDA CDER + CBER BTDs Denied by the FDA remains the same at 114

•   The total # of FDA CDER + CBER BTDs Pending by the FDA increases from 31 to 36.

FDA CBER + CDER BTDs as of 07/25/14

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-06/30/14) Total # of CDER Designations (07/09/12-07/25/14) Total # of CBER +   CDER BTD Designations (07/09/12-07/25/14)
Total # of BTD Requests Received 31 175 206
Total # of BTDs Granted 4 52 56
Total # of BTDs   Denied 26 88 114
Total # of BTDs   Pending 1 35 36

.

OBSERVATIONS

•   27.2 %    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

•   17.5 % 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.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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