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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 05/01/15)

May 6, 2015

 

 

The CBER BTD #s are current as of 04/30/15 and the CDER BTD #s are current as of 05/01/15.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 297 to 300

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 85 to 88

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 158 to 161

•   The total # of FDA CDER + CBER BTDs Pending by the FDA decreases from 54 to 51.

FDA CBER BTDs + CDER BTDs (as of 05/01/15) 

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-04/30/15) Total # of CDER Designations (07/09/12-05/01/15) Total # of CBER +   CDER BTD Designations (07/09/12-05/01/15)
Total # of BTD Requests Received 50 250 300
Total # of BTDs Granted 12 76 88
Total # of BTDs   Denied 34 127 161
Total # of BTDs   Pending 4 47 51

.

OBSERVATIONS

•   29.3 % of the total # of BTD Requests Received results in the BTD being granted

•   53.7 % of the total # of BTD Requests Received results in the BTD being denied

•   17.0 % 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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