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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 09/19/14)

September 25, 2014

The CBER BTD #s are current as of 08/31/14 and the CDER BTD #s are current as of 09/19/14.

The changes are as follows :

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 217 to 221

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 62 to 63

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 120 to 122

•   The total # of FDA CDER + CBER BTDs Pending by the FDA increases from 35 to 36.

FDA CBER + CDER BTDs (as of 09/19/14)

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-08/31/14) Total # of CDER Designations (07/09/12-09/19/14) Total # of CBER +   CDER BTD Designations (07/09/12-09/19/14)
Total # of BTD Requests Received 34 187 221
Total # of BTDs Granted 6 57 63
Total # of BTDs   Denied 26 96 122
Total # of BTDs   Pending 2 34 36

.

OBSERVATIONS

•   28.5 % of the total # of BTD Requests Received results in the BTD being granted

•   55.2 % of the total # of BTD Requests Received results in the BTD being denied

•   16.3 % 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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