How was the first-ever allogeneic cell-based product approved by the FDA?

In Regulation and Compliance by matt turnerLeave a Comment

The market approval of GINTUITâ„¢, for the regeneration of oral soft tissue, is the first for an allogeneic cell therapy product. At the World Stem Cell & Regenerative Medicine Congress 2012, Geoff MacKay, CEO of Organogenesis, will reveal all about the path to a CBER FDA approval and what specifically have been the learnings along the regulatory pathway. This will be a great opportunity for the 2012 delegation to hear about a landmark success story for the regenerative medicine industry and see how Organogenesis' experiences and lessons learned can be applied to their own portfolio to ensure similar success.

Over 250 attendees have confirmed to attend the World Stem Cell & Regenerative Medicine Congress and registration remains open for the next few weeks. See what else is in store by downloading the congress brochure.

You can also read the thoughts of other stem cell industry executives who are speaking at the World Stem Cell & Regenerative Medicine Congress 2012 – Gary Rabin, CEO of Advanced Cell Technology and Yael Margolin, CEO of Gamida Cell

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