FDA Breakthrough Therapy Designation Statistics Chart

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•   The CBER BTD #s are current as of 05/31/15 & the CDER BTD #s are current as of 05/29/15

•   The FDA updates the CBER BTD #s monthly & updates the CDER BTD #s every 2 weeks.

 

FDA CBER BTDs + CDER BTDs (as of 05/31/15) 

Breakthrough Therapy  Designation (BTD) Category	Total # of CBER Designations (07/09/12-05/31/15)	Total # of CDER Designations (07/09/12-05/29/15)	Total # of CBER +   CDER BTD Designations (07/09/12-05/31/15)
Total # of BTD Requests Received	50	258	308
Total # of BTDs Granted	12	78	90
Total # of BTDs   Denied	37	132	169
Total # of BTDs   Pending	1	48	49

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Seventy-one (71) BTDs have been identified by the sponsor companies as of June 4, 2015.  With 90 total BTDs granted, there are 19 that have not been identified by the sponsor company.

Per the FDA website:

“FDA will not disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designation. Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a).”

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

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