stem cell meeting

R3 Stem Cell still raises red flags for me after FDA letter including do one-get one meeting

R3-Stem-Cell-Course

Back in May, the FDA cautioned a stem cell clinic firm called R3 Stem Cell and its leader David Greene about what they were doing. Importantly, the agency indicated that some of R3’s stem cells may be unapproved drug products. While the FDA didn’t send R3 Stem Cell a formal warning letter, in my view the …

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Guide to September 12-13 FDA Stem Cell Meeting

Stembucks

The FDA is holding a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees? Who is likely to say what? If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have …

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Blogging today’s FDA stem cell meeting: Part 1

FDA-stem-cells

The FDA is holding its first 2016 stem cell meeting today. How’s the meeting going? The meeting start awfully early for us West Coast folks (5:30am) so I didn’t get to see the first few talks. Did anyone else see those and if so, what was your impression? From the talks I have seen, this meeting …

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New FDA Interview on April stem cell meeting & draft guidances

FDA-draft-guidance

Below is a my interview with an FDA spokesperson on the upcoming April public meeting on the four recent draft guidances related to the regulation of HCT/Ps, including stem cell treatments. This meeting and the draft guidances could have substantial impact on future regulatory frameworks for stem cell treatments so I thought it important to …

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Good reasons to go to the World Stem Cell Summit

WSCS

By Heather Main This year I will be attending the World Stem Cell Summit for the first time (see @WSCSummit on Twitter). I was surprised when I looked at the program and recognized so few of the names of speakers; which made me question what this event was about, if not focused on stem cell research. …

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