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FDA Enforcement

Webinar Examines FDA Regenerative Medicine Rules Enforcement

The grace period is over, and the FDA is moving forward to enforce rules for clinics and others providing unapproved regenerative products, especially those said to be based on stem cells.

How this could play out is explored in a webinar, “End of the FDA Enforcement Discretion Period and Its Impact,” produced by the International Society for Cell and Gene Therapy (ISCT). The webinar panelists include representatives of the FDA and the Alliance for Regenerative Medicine, a U.S. Senator and a bioethicist. They discuss and answer questions about recent and expected FDA actions against clinics that promote and offer unauthorized treatments, including unapproved birthing tissue-derived products.

The archived webinar is open access.

 

Access the Webinar



Next Saturday Is Cord Blood Connect Abstract Deadline

Only a week remains until the July 31 deadline for submitting abstracts for the Cord Blood Connect international congress that will be held virtually on Sept. 23 and 30. Accepted abstracts will be published in STEM CELLS Translational Medicine, indexed in the medical literature, and eligible for Best Abstract awards with oral presentation during the congress. Click the link for abstract categories, preparation guidelines and submission.

 

Submit an Abstract