Almost none have completed the large, long-term human trials that would tell us whether theyre safe to use for months or years
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The July 23 PCAC meeting will evaluate its eligibility for the 503A Bulks List before FDA makes a final decision
Specifically, these are as follows: While current research on L-carnitine in DED is limited, its potential effects on energy metabolism, antioxidant capabilities, and cell signaling pathways could enhance lacrimal cell health and function
That is defensive rather than constructive work
Natural history studies in areas targeted for efficacy trials seem essential, in particular in the context of PZQ MDA