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Thursday, 03/08/2018 8:21:19 PM

Thursday, March 08, 2018 8:21:19 PM

Post# of 106834
This is big news!

https://www-m.cnn.com/2018/03/08/health/stem-cell-therapy-fda-bn/index.html

The FDA will provide tools to encourage individual or small groups of physicians to collaborate in support of the development of a stem cell or other regenerative medicine product, they wrote.
Gottlieb and Marks also said the FDA is encouraging investigators who are involved in such innovative product development to engage in dialogue with the agency early on in the research process.
"It feels like the FDA leadership is in essence telling them, 'Do the right thing, and we'll help you with a trial, even if you aren't a big university or company,' " Knoepfler said. "It's reassuring to see though that the FDA still emphasizes it is crucial to have data and follow the rules."