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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 10/17/14)

October 23, 2014

The CBER BTD #s are current as of 09/30/14 and the CDER BTD #s are current as of 10/17/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 228 to 239

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 65 to 67

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 124 to 126

•   The total # of FDA CDER + CBER BTDs Pending by the FDA increases from 39 to 46.

FDA CBER BTDs + CDER BTDs (as of 10/17/14)

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-09/30/14) Total # of CDER Designations (07/09/12-10/17/14) Total # of CBER +   CDER BTD Designations (07/09/12-10/17/14)
Total # of BTD Requests Received 37 202 239
Total # of BTDs Granted 7 60 67
Total # of BTDs   Denied 26 100 126
Total # of BTDs   Pending 4 42 46

.

OBSERVATIONS

•   28.0 % of the total # of BTD Requests Received results in the BTD being granted

•   52.7 % of the total # of BTD Requests Received results in the BTD being denied

•   19.3 % 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: FDA Official Logo from FDA website.

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

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