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Stem Cell Processor, IRB Targets of Related Warning Letters from FDA

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The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority Read More...

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Former FDA Official Slams Regulation of Stem Cells as Exceeding Agency Authority

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Should the US Food and Drug Administration (FDA) have the authority to regulate cells derived from—and later put back into—a person?A recent opinion-editorial published in The Wall Street Journal by Read More...

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US Court: Stem Cells may be Regulated as Drugs

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The US District Court in Washington, DC, has ruled that the US Food and Drug Administration (FDA) may legally regulate stem cell therapies as drug products—an opening salvo in what is likely to be a Read More...

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Stem Cell Processor, IRB Targets of Related Warning Letters from FDA

Former FDA Official Slams Regulation of Stem Cells as Exceeding Agency Authority

US Court: Stem Cells may be Regulated as Drugs

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