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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 08/31/14)

September 8, 2014

The CBER BTD #s are current as of 08/31/14 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 215 to 217

•   The total # of FDA CDER + CBER BTDs Granted by the FDA remains the same at 61

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 117 to 118

•   The total # of FDA CDER + CBER BTDs Pending by the FDA increases from 37 to 38.

FDA CBER + CDER BTDs as of 08/31/14

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-08/31/14) Total # of CDER Designations (07/09/12-08/22/14) Total # of CBER +   CDER BTD Designations (07/09/12-08/31/14)
Total # of BTD Requests Received 34 183 217
Total # of BTDs Granted 6 55 61
Total # of BTDs   Denied 26 92 118
Total # of BTDs   Pending 2 36 38

.

OBSERVATIONS

•   28.1 %    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

•   17.5 % 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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