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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 04/17/15)

April 28, 2015

 

 

The CBER BTD #s are current as of 03/31/15 and the CDER BTD #s are current as of 04/17/15.

The changes are as follows:

  1. The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 295 to 297
  2. The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 84 to 85
  3. The total # of FDA CDER + CBER BTDs Denied by the FDA remains the same at 158
  4. The total # of FDA CDER + CBER BTDs Pending by the FDA increases from 53 to 54.

FDA CBER BTDs + CDER BTDs (as of 04/17/15) 

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-03/31/15) Total # of CDER Designations (07/09/12-04/17/15) Total # of CBER +   CDER BTD Designations (07/09/12-04/17/15)
Total # of BTD Requests Received 49 248 297
Total # of BTDs Granted 11 74 85
Total # of BTDs   Denied 34 124 158
Total # of BTDs   Pending 4 50 54

.

OBSERVATIONS

  1. 28.6 % of the total # of BTD Requests Received results in the BTD being granted
  2. 53.2 % of the total # of BTD Requests Received results in the BTD being denied
  3. 18.2 % 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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