FDA stem cell meeting

Cons Outweigh Potential Pros to BPC Plan on Stem Cells & FDA

BPC-report-stem-cels

There is considerable interest in FDA regulatory reform here in the U.S. for stem cell therapies. The goal is to get new treatments to patients faster, but is there a way to do that without sacrificing proven safety and efficacy? You need convincing data on both safety and efficacy or speed becomes dangerous. A group called …

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New FDA Interview on April stem cell meeting & draft guidances

FDA-draft-guidance

Below is a my interview with an FDA spokesperson on the upcoming April public meeting on the four recent draft guidances related to the regulation of HCT/Ps, including stem cell treatments. This meeting and the draft guidances could have substantial impact on future regulatory frameworks for stem cell treatments so I thought it important to …

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