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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

The appropriate product route depends on the purchasers own research planning, inventory requirements and institutional procedures

It has not gone through the approval process that establishes safety and efficacy for a defined clinical use, and it should be understood as investigational and research-only

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