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And so FDA is going to need to use a different lens. Unlike FDA approval of a new drug, which requires years of clinical trials demonstrating safety and effectiveness, placement on the 503A Bulks List answers a different regulatory question
Because it stimulates GH release without significantly disrupting other hormonal systems, researchers can study its effects with greater clarity and fewer confounding variables than many alternative secretagogues allow
Use of long-term drugs
Storage & Handling Store in a cool, dry environment away from direct light and moisture
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