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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 01/23/15)

January 28, 2015

 

 

The CBER BTD #s are current as of 12/31/14 and the CDER BTD #s are current as of 01/23/15.

The changes are as follows:

•    The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 269 to 273

•    The total # of FDA CDER + CBER BTDs Granted by the FDA remains the same at 74

•    The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 139 to 142

•    The total # of FDA CDER + CBER BTDs Pending by the FDA increases from 56 to 57.

FDA CBER BTDs + CDER BTDs (as of 01/23/15)

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-12/31/14) Total # of CDER Designations (07/09/12-01/23/15) Total # of CBER +   CDER BTD Designations (07/09/12-01/23/15)
Total # of BTD Requests Received 46 227 273
Total # of BTDs Granted 8 66 74
Total # of BTDs   Denied 30 112 142
Total # of BTDs   Pending 8 49 57

.

OBSERVATIONS

•   27.1 % of the total # of BTD Requests Received results in the BTD being granted

•   52.0 % of the total # of BTD Requests Received results in the BTD being denied

•   20.9 % 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 © 2012-2015, Orphan Druganaut Blog. All rights reserved.

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