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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 08/22/14)

August 28, 2014

The CBER BTD #s are current as of 07/31/14 and the CDER BTD #s are current as of 08/22/14.

The changes are as follows :

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 207 to 215

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 58 to 61

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 113 to 117

•   The total # of FDA CDER + CBER BTDs Pending by the FDA increases from 36 to 37.

FDA CBER + CDER BTDs as of 08/22/14

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-07/31/14) Total # of CDER Designations (07/09/12-08/22/14) Total # of CBER +   CDER BTD Designations (07/09/12-08/22/14)
Total # of BTD Requests Received 32 183 215
Total # of BTDs Granted 6 55 61
Total # of BTDs   Denied 25 92 117
Total # of BTDs   Pending 1 36 37

.

OBSERVATIONS

•   28.4 %    of the total # of BTD Requests Received results in the BTD being granted

•   54.4 % of the total # of BTD Requests Received results in the BTD being denied

•   17.2 % 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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