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FDA’s CBER fires off 3 more warning letters on cellular biologics for a total of 12 in 2024

Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on cell and tissue biologics CBER is the part of the FDA that regulates regenerative medicine products like stem cells,

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Big spike in FDA warning letters to unproven biologics firms

Dr. Peter Marks, Director of CBER, FDA warning

This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve

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Regener-Eyes maker gets FDA warning on amniotic eye drops

Regener-Eyes

The FDA alerted the public about issues related to amniotic eye drops last year and now the agency just warned the manufacturer of one such product called Regener-Eyes. The manufacturer is Regenerative Processing Plant, LLC. The warning letter was addressed to its owner, Carl R. Harrell, MD. What’s the deal with this warning? Let’s start

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Weekly reads: stem cell shampoo, Neobiosis FDA warning, trogocytosis

stem cell shampoo

Even for a stem cell research wonk like me the broader regenerative arena never ceases to surprise me with the latest thing being stem cell shampoo. Stem cell shampoo A news item that seems promotional discussed the stem cell shampoo as yielding positive results. So after you are done with your vampire facelift, stem cell

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Another state challenges FDA on biologics as Nevada OKs risky, unproven oligo, gene, & other therapies

Julie Pazina, Nevada law biologics

Nevada has a relatively new 2023 law legalizing non-FDA-approved biological and gene therapies. I use the word “therapies” here loosely.  They are not scientifically or medically proven to work or be safe so they could lead to substantial harm. This is yet another early step in a likely growing trend of states challenging FDA authority

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Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem

Robert Califf, FDA Commissioner

FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I

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Recommended reads: FDA warning on stem cells for pets, chromatin, aging & HSCs

Safari Stem Cell, stem cells for pets

When I first saw the new FDA warning on stem cells for pets and the logo for the company that received it, I was surprised in a few ways. I don’t recall ever seeing such a letter and the logo is something else. We’ll get into all of that in a moment, but first, since

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