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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 12/12/14)

December 29, 2014

 

 

The CBER BTD #s are current as of 11/30/14 and the CDER BTD #s are current as of 12/12/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 250 to 252

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 71 to 72

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 133 to 135

•   The total # of FDA CDER + CBER BTDs Pending by the FDA decreases from 46 to 45.

FDA CBER BTDs + CDER BTDs (as of 12/12/14)

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-11/30/14) Total # of CDER Designations (07/09/12-12/12/14) Total # of CBER +   CDER BTD Designations (07/09/12-12/12/14)
Total # of BTD Requests Received 39 213 252
Total # of BTDs Granted 8 64 72
Total # of BTDs   Denied 29 106 135
Total # of BTDs   Pending 2 43 45

.

OBSERVATIONS

•   28.6 % of the total # of BTD Requests Received results in the BTD being granted

•   53.6 % of the total # of BTD Requests Received results in the BTD being denied

•   17.8 % 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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