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What is an FDA warning letter & how should firms respond

FDA warning letter

Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today’s post is to explain what an FDA warning letter is all about. This analysis includes what such a letter means and what steps come …

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Weekly reads: Jan Nolta recognition, new director after Irv, FDA guidance

Dr. Jan Nolta UC Davis

People are the real driving force in the stem cell and regenerative medicine field including my colleague Jan Nolta here at UC Davis. She is the Director of our Stem Cell Program. There’s also news about Stanford’s stem cell Director Irv Weissman. Jan Nolta receives award Jan’s lab is prolific and in many ways is …

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One size doesn’t fit all? FDA may soften some cell therapy regs

dr. peter marks fda, cell therapy

The Pink Sheet just broke the story that the FDA may change up its oversight of the cell therapy space. This possible shift could drop the oversight bar somewhat for certain products. Most likely it’d be those with lower anticipated risks. The Pink Sheet piece by Sue Sutter is titled US FDA To Explore New Regulatory Pathways …

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End of FDA “grace period” impacted perinatal cell therapy biotechs

knot in umbilical cord, perinatal cell therapy

If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in …

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FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance

FDA-draft-guidance

The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …

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Weekly reads: possible rare HIV cure, stem cell chicken, FDA commish

HIV infected T cell, HIV cure

The idea of stem cells outright curing diseases is exciting and has powerful appeal, but media need to be careful about using the word cure in headlines and articles as we saw this week related to a possible HIV Cure. HIV cure via stem cells and chemo? The big news of the week was that …

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Weekly stem cell reads: COVID kidney, FDA letter, H3.3, EO Wilson

EO Wilson

Happy New Year and get ready for another 364 more days of stem cell excitement and craziness in 2022. In the next day or two I’ll post my predictions for this new year. Recommended reads EO Wilson obit by Carl Zimmer in NYT. Who’s the next EO Wilson or someone like him with such big impact these …

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Regenerative reads: 3 CRISPR babies, FDA warning, diabetes, pubs

CRISPR-baby

If you celebrate the Thanksgiving holiday I hope you had a nice one and, right before it started a new article popped on the scene about the CRISPR babies. Before we discuss those three gene-edited people, who are now growing up into little kids, we hit a milestone on our YouTube Stem Cell Channel with …

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Turner pub charts runaway stem cell clinic industry; FDA needs to think big now

U.S. Stem cell clinics map 2021.

Leigh Turner’s new Cell Stem Cell paper on the unproven stem cell clinic industry following up on our collaborative work together in 2015-2016 is great work but very discouraging. He found more than 2,700 clinics run by more than 1,000 firms in the U.S. This is several-fold growth since 2016. I’m very glad that Leigh has continued this line of …

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Weekly stem cell reads: pending FDA verdict, blood vessels, RA

Cellular populations in the vascular wall, stem cell niche

Any day now we should get the verdict from the judge in the big stem cell clinic case here in California against Cell Surgical Network, et al. It seems that the FDA is waiting on this verdict before taking some major actions. If the judge rules against the agency it could throw the area into …

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