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This is genuinely notable because it came against the FDA's own staff scientists' recommendation: the agency's briefing documents had proposed the opposite conclusion for all seven peptides under review, citing a lack of quality data supporting safety and effectiveness, and a more fundamental "foundational challenge" — that the FDA can't yet clearly define what these substances even are, given how much variation exists between different suppliers' products sold under the same name

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7.3.2.2 In vitro model system development Current efforts to develop organoid models of human testicular tissue remain in early experimental phases, with significant technical challenges limiting their immediate applicability to EED research