Post-Market Surveillance Gap: Because AOD-9604 never received FDA approval for any indication, there is no post-market surveillance system capturing safety signals from widespread clinical use
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Supports cardiovascular health by improving blood flow and heart function May improve cognitive function and brain health Supports muscle recovery and reduces muscle fatigue Helps regulate blood sugar levels Can boost immune system function
Comments submitted after July 9 but before the July 22 docket closure will still be considered by FDA, but will not go directly to the Committee
However, markedly elevated levels without supplementation may warrant GP review to exclude underlying conditions such as haematological disorders, liver disease, or renal impairment