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- Consumer Alert on Regenerative Medicine Products Including Stem Cells
FDA encourages patients to report Adverse Events Related to Stem Cells, Exosomes, or Other Products Marketed as Regenerative Medicine Products
- FDA Warns About Stem Cell Therapies
Español Researchers hope stem cells will one day be effective in the treatment of many medical conditions and diseases But unproven stem cell treatments can be unsafe—so get all of the facts
- FDA puts company on notice for marketing unapproved stem cell products . . .
In the FDA’s review of the R3 Stem Cell, LLC website, the agency found that the company promotes stem cell therapies for numerous diseases or conditions, such as dementia and Parkinson’s
- Important Patient and Consumer Information About Regenerative Medicine . . .
There continues to be broad marketing of unapproved products considered regenerative medicine therapies that are intended for the treatment or cure of a wide range of diseases or medical
- FDA sends warning to company for marketing dangerous unapproved stem . . .
FDA News Release FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice Genetech, Inc
- January 16, 2024 Untitled Letter - Vitacell Biologics, LLC
Based on our review of your website, you have sold Vitacell and Vitacell Pro, cellular products derived from human umbilical cord, which you refer to as “stem cells” or “stem cell therapy
- Federal court issues decision holding that US Stem Cell clinics and . . .
The FDA initially raised concerns about US Stem Cell in a warning letter issued in 2017 for marketing stem cell products without FDA approval and for significant deviations from current good
- Cellular Gene Therapy Products | FDA
The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy
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