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Grey market vendors skip the costs that make pharmaceutical peptides expensive: clinical trials ($50M-$2B+), FDA approval processes, GMP-certified manufacturing facilities, prescription distribution chains, and pharmaceutical-grade packaging

Neurology 67 , 16001604 (2006)

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Regulationsrules that must be followed and rules having the force of lawissued by the US Food and Drug Administration (FDA), it can be argued, are designed to raise the performance of all parties in biopharmaceuticals to an acceptable (and enforceable) standard