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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 10/03/14)

October 8, 2014

The CBER BTD #s are current as of 09/30/14 and the CDER BTD #s are current as of 10/03/14.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 221 to 228

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 63 to 65

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 122 to 124

•   The total # of FDA CDER + CBER BTDs Pending by the FDA increases from 36 to 39.

FDA CBER + CDER BTDs as of 10/03/14)

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-09/30/14) Total # of CDER Designations (07/09/12-10/03/14) Total # of CBER +   CDER BTD Designations (07/09/12-10/03/14)
Total # of BTD Requests Received 37 191 228
Total # of BTDs Granted 7 58 65
Total # of BTDs   Denied 26 98 124
Total # of BTDs   Pending 4 35 39

.

OBSERVATIONS

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

•   54.4 % of the total # of BTD Requests Received results in the BTD being denied

•   17.1 % 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 © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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