Search Results for: warning letter

New data on stem cell clinics, INDs, & more including from FDA itself

arm slide fda trip program

The International Society for Cell & Gene Therapy or ISCT held a really interesting webinar yesterday on the FDA and unproven stem cell clinics. It was focused on the expiration of the FDA’s discretionary period on unproven stem cell clinics. What will the FDA do now? The webinar included some ideas and also quite a […]

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FDA to end ‘grace period’ on stem cell clinics: agency should ‘go big’ on continued offenders

stem cell clinics map

Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics

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Perspectives on BioLife: one name, distinct companies

boston biolife

In the stem cell world some corporate names end up being very similar with the latest example being several companies with the name “BioLife.” Get a BioLife…name I guess BioLife is a catchy term. You’ve got life and biology in there in one name. Let’s deconstruct what’s going on out there with this corporate name.

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21 Stem Cell Research & Regenerative Medicine 2021 Predictions

stem-cell-crystal-ball-300x3001

In any given field of biomedical science like stem cell research and regenerative medicine, it’s very useful if you can accurately predict the future. It seems, though, that predictions are far more difficult within the more exciting and rapidly-changing fields. The field of stem cells and regenerative medicine fits that bill. Past stem cell research

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Jellyfish on the brain: a critical look at Prevagen

crystal jellyfish aequorea victoria, Prevagen

I’ve been asked many times over the years if stem cell injections at for-profit clinics can help brain function, but recently the more common query is whether brain supplements such as Prevagen actually work. I’m skeptical of both unproven stem cell injections and supplements that are supposed to somehow help the brain, but some of

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Stem cell reads: liver buds, MSCs, SMARC, more

Liver-buds-from-stem-cells

It’s fitting, given the edginess over the election, that Halloween is falling only a few days before election day so here is a list of recommended stem cell reads for you to dive into some biomedical science. Liver buds from stem cells Generation of human induced pluripotent stem cell-derived liver buds with chemically defined and

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