1. Pink Sheet

RAT Race Begins: FDA Accepting Regenerative Advanced Therapy Designation Requests

 
• By Michael McCaughan

As part of a flurry of actions in the waning days of the Obama Administration, FDA formally announced a process for requesting the new “Regenerative Advanced Therapy” designation. Much like the early days of “Breakthrough,” the standards are uncertain for now.

FDA’s newest “special status” pathway is open for business – but sponsors may wonder how best to announce the receipt of a “RAT” as a good news event.

FDA has, apparently, decided on RAT as the straightforward acronym for the “Regenerative Advanced Therapy” designation, created by the 21st Century Cures Act that became law Dec. 13. (Also see...

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