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its up to the FDA, and right now, these specific peptides sit outside it. The biggest risk to this potential pathway, Robinson explains, is reporting of adverse events, which the FDA describes as any undesirable experience associated with the use of a medical product in a patient. Should an adverse event happen, Robinson says it could negatively impact or delay the rulemaking process. As the FDA pointed out in their official meeting recommendation to keep the peptides under their current restrictions, these peptides simply dont have adequate clinical data behind them

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doi:10.1098/rsbm.2002.0011