Wait, there’s an FDA stem cell meeting this week too? The scoop

stem cell crystal ball

Stem cell Crystal Ball

There’s a big FDA stem cell meeting coming along next week that has gotten much attention, but many people didn’t realize there’s also an FDA meeting on stem cells this week too in three days on September 8th.

I pasted this week’s meeting schedule at the bottom of this post from the FDA page. The meeting is a workshop entitled, “Public Workshop: Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval”.

The meeting next week on September 12-13 getting all the attention is entitled, “Draft Agenda: Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products”.

Within the “Human Cells, Tissues, and Cellular and Tissue-Based Products” or HCT/P larger category the ones getting the most attention are stem cells. If you look at the speakers at this week’s meeting including the keynote by Irv Weissman, it’s pretty clear this meeting is focused squarely on stem cells even though it could apply to other products.

What’s the difference between the meetings?

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ISSCR Releases Flood of Stem Cell Policy Docs

A committee of the International Society for Stem Cell Research (ISSCR) did one heck of a document dump yesterday on stem cell policy, releasing a whole bunch of policy recommendations on stem cells and more.

The torrent from ISSCR included a 37-page policy statement itself as well as several papers in top journals including the Lancet, Science, and Nature.

This output was the product of the members of a special  ISSCR Task Force, whose members I have listed at the bottom of this post. Who are the members? These are knowledgable, extremely bright people who care deeply about the issues.

ISSCR Policy Guidelines 2016

The stem cell policy positions of ISSCR and those in the associated publications were wide-ranging, touching upon everything from avoiding stem cell research hype to policies on human embryos to CRISPR of human embryos to three-person IVF/mitochondrial transfer, to clinical trials generally to patient-funded trials and more.

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