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We believe transitioning the manufacturer from the severe supply chain disruption reduction or the likely to be in shortage reduction to the shortage reduction, by beginning the shortage reduction clock as set forth in 428.301(b)(2)(i)(A) or (b)(2)(ii)(A) after the severe supply chain disruption reduction or likely to be in shortage reduction no longer applies, and gradually declining the rebate reduction over time could help prevent exacerbation of the shortage

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Read article Regulatory context 7 min read FDA Announces July 2026 Review of BPC-157, TB-500, Semax, Epitalon and Other Peptides Neutral research catalog context for the FDA's July 23-24, 2026 advisory committee agenda covering several peptide-related bulk drug substances

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