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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

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[5] Scientific References Dietary Reference Values for Food Energy and Nutrients for the United Kingdom (COMA Report)

Persistent or expanding reactions warrant clinician review

The 5mg/ml concentration gives you whole numbers or simple halves at every standard dose level