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FDA Breakthrough Therapy Designations: Statistics Updated (As of 09/20/13)

September 23, 2013

The FDA CDER + CBER Breakthrough Therapy Designation (BTD) statistics have been updated as of 09/20/13.  The changes are as follows:

•   The total # of FDA CDER + CBER BT Requests received by the FDA increases from 95 to 99
•   The total # of FDA CDER + CBER BTs Granted by the FDA increases from 27 to 28
•   The total # of FDA CDER + CBER BTs Denied by the FDA increases from 43 to 48
•    The total # of FDA CDER + CBER BTs Pending by the FDA decreases from 25 to 23.

A few observations about the statistics as of 09/23/13:

•   Approximately 48.5 % of the FDA CDER BTDs + CBER BTDs requests received have been denied
•   Approximately 28 %    of the FDA CDER BTDs + CBER BTDs requests received have been granted
•   Approximately 23 %    of the FDA CDER BTDs + CBER BTDs requests received are pending

•   Approximately 86%     of the FDA CDER BTDs + CBER BTDs granted have been identified by sponsor companies.

The latest “FDA CDER + CBER Breakthrough Therapy Designation Statistics Chart” will always be located at URL http://wp.me/p2w211-1tA, so please bookmark.

The latest “FDA Breakthrough Therapy Designation Chart” Blog Post will always be located at URL http://wp.me/p2w211-1mO, so please bookmark.

Please Note: “Idea” PNG by Producer at ar.wikipedia (Transferred from ar.wikipedia) [Public domain] | Wikimedia Commons.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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