FDA announces comprehensive regenerative medicine policy framework

See the documents here.
Here’s what Fierce Biotech has to say: “While aspects of the framework are intended to ensure effective regenerative medicines reach patients as soon as possible, FDA commissioner Scott Gottlieb, M.D., also framed it as an attempt to curb the rise of cellular therapies from unscrupulous providers.

“Alongside all the promise, we’ve also seen products marketed that are dangerous and have harmed people,” Gottlieb said in a statement. “With the policy framework the FDA is announcing today, we’re adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities.””

Please follow and like Sonia Arrison:
FDA announces comprehensive regenerative medicine policy framework

Leave a Reply

Your email address will not be published.