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This is crucial
Understanding any negative effects of current practice and how GPs can better meet the needs of this marginalised group is key to improving safety and care, they concluded
Officially, the FDA cites: Insufficient large-scale clinical trials Concerns about consistency, sourcing, and manufacturing standards The need to meet formal drug approval requirements Critics argue (fairly) that this system: Favors large pharmaceutical companies Makes it hard to approve naturally occurring peptides Leaves promising, low-risk compounds in regulatory limbo The short version: This FDA restrictive regulatory change of mind wasnt driven by a sudden safety scare, it was driven by regulatory process and economics
A systematic review in 2024 identified 36 studies (35 preclinical, 1 clinical) from 1993 to 2024
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