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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 03/31/15)

April 6, 2015

 

 

The CBER BTD #s are current as of 03/31/15 and the CDER BTD #s are current as of 03/20/15.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 291 to 293

•   The total # of FDA CDER + CBER BTDs Granted by the FDA remains the same at 82

•   The total # of FDA CDER + CBER BTDs Denied by the FDA remains the same at 155

•   The total # of FDA CDER + CBER BTDs Pending by the FDA increases from 54 to 56.

FDA CBER BTDs + CDER BTDs (as of 03/31/15)

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-03/31/15) Total # of CDER Designations (07/09/12-03/20/15) Total # of CBER +   CDER BTD Designations (07/09/12-03/31/15)
Total # of BTD Requests Received 49 244 293
Total # of BTDs Granted 11 71 82
Total # of BTDs   Denied 34 121 155
Total # of BTDs   Pending 4 52 56

.

OBSERVATIONS

•   28.0 % of the total # of BTD Requests Received results in the BTD being granted

•   52.9 % of the total # of BTD Requests Received results in the BTD being denied

•   19.1 % 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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