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

December 1, 2014

 

 

The CBER BTD #s are current as of 10/31/14 and the CDER BTD #s are current as of 11/14/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 239 to 247

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 67 to 69

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 126 to 130

•   The total # of FDA CDER + CBER BTDs Pending by the FDA increases from 46 to 48.

FDA CBER BTDs + CDER BTDs (as of 11/14/14)

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-10/31/14) Total # of CDER Designations (07/09/12-11/14/14) Total # of CBER +   CDER BTD Designations (07/09/12-11/14/14)
Total # of BTD Requests Received 38 209 247
Total # of BTDs Granted 7 62 69
Total # of BTDs   Denied 27 103 130
Total # of BTDs   Pending 4 44 48

.

OBSERVATIONS

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

•   52.6 % of the total # of BTD Requests Received results in the BTD being denied

•   19.5 % 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: FDA Official Logo from FDA website.

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

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