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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 07/11/14)

July 14, 2014

The CBER BTD #s are current as of 06/30/14 and the CDER BTD #s are current as of 07/11/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 195 to 201

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 52 to 56

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 108 to 114

•   The total # of FDA CDER + CBER BTDs Pending by the FDA decreases from 35 to 31.

FDA CBER + CDER BTDs as of 07/11/14

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-06/30/14) Total # of CDER Designations (07/09/12-07/11/14) Total # of CBER +   CDER BTD Designations (07/09/12-07/11/14)
Total # of BTD Requests Received 31 170 201
Total # of BTDs Granted 4 52 56
Total # of BTDs   Denied 26 88 114
Total # of BTDs   Pending 1 30 31

.

OBSERVATIONS

•   27.9 %    of the total # of BTD Requests Received results in the BTD being granted

•   56.7 % of the total # of BTD Requests Received results in the BTD being denied

•   15.4 % 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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