Spectral Medical Inc T.EDT

RE:RE:RE:RE:RE:RE:Don’t ignore the Bashers…

[mercedesman]

Not quite Gorf, but still encouraging !

Half Of US FDA’s Breakthrough Therapy Designations Have Resulted In Approval :: Pink Sheet (informa.com)

Half of the clinical programs awarded breakthrough therapy designations have gone on to receive FDA approval, making the BTD one of the most successful of the FDA’s expedited review pathways, according to an analysis of the Pink Sheet’s US FDA Performance Tracker.

The FDA has awarded 437 BTDs since the program was introduced by the 2012 FDA Safety and Innovation Act (FDASIA). The Pink Sheet has identified 397 designations, which are tracked in detail on the Performance Tracker’s Breakthrough Therapy Designations chart. The FDA has granted approval to 206 of the known designated programs. (See infographic at the end of the story.)

In contrast, fast track status has been conferred on 1,388 drug programs since the program was established by the 1997 FDA Modernization Act (FDAMA), according to BioMedTracker, and has resulted in 258 approvals – only about 20% of the designations.

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The relative success of the BTD pathway reflects the higher bar to receive the designation compared with fast track status. The pathways are not mutually exclusive, and both aim to speed development of products intended to treat serious conditions.