Skip to content

FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 04/03/15)

April 17, 2015

 

 

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

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 293 to 295

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 82 to 84

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 155 to 58

•   The total # of FDA CDER + CBER BTDs Pending by the FDA decreases from 56 to 53.

FDA CBER BTDs + CDER BTDs (as of 04/03/15)

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-03/31/15) Total # of CDER Designations (07/09/12-04/03/15) Total # of CBER +   CDER BTD Designations (07/09/12-04/03/15)
Total # of BTD Requests Received 49 246 295
Total # of BTDs Granted 11 73 84
Total # of BTDs   Denied 34 124 158
Total # of BTDs   Pending 4 49 53

.

OBSERVATIONS

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

•   53.5 % of the total # of BTD Requests Received results in the BTD being denied

•   18.0 % 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.

Advertisements
Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: