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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 05/31/15)

June 3, 2015
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The CBER BTD #s are current as of 05/31/15 and the CDER BTD #s are current as of 05/29/15.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 304 to 308

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 88 to 90

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 163 to 169

•   The total # of FDA CDER + CBER BTDs Pending by the FDA decreases from 53 to 49.

FDA CBER BTDs + CDER BTDs (as of 05/31/15) 

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-05/31/15) Total # of CDER Designations (07/09/12-05/29/15) Total # of CBER +   CDER BTD Designations (07/09/12-05/31/15)
Total # of BTD Requests Received 50 258 308
Total # of BTDs Granted 12 78 90
Total # of BTDs   Denied 37 132 169
Total # of BTDs   Pending 1 48 49

.

OBSERVATIONS

•   29.2 % of the total # of BTD Requests Received results in the BTD being granted

•   54.9 % of the total # of BTD Requests Received results in the BTD being denied

•   15.9 % 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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