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FDA Breakthrough Therapy Designations: Statistics Updated (As of 08/23/13)

August 26, 2013

The FDA CDER + CBER Breakthrough Therapy (BT) Designation statistics have been updated as of 08/23/13.  The changes are as follows:

  1. The total # of FDA CDER + CBER BT Requests received by the FDA is 92
  2. The total # of FDA CDER + CBER BTs Granted by the FDA is 26
  3. The total # of FDA CDER + CBER BTs Denied by the FDA is 40
  4.  The total # of FDA CDER + CBER BTs Pending by the FDA is 26.

The Orphan Druganaut Blog Post that will always contain the latest “FDA CDER 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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  1. Will ACTC get Breakthrough Designation by 12/31/13?

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