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The FDA also agreed to change a full clinical hold for the trial to a partial clinical hold pending review and approval of the company's proposed protocol for a 6-month, Phase I study to assess the potential relevance of adverse findings observed in long-term animal studies of metadoxine in relation to human exposure, Alcobra said

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The FDA generally gives a 60-day grace period to allow 503B compounding pharmacies to fulfill any product orders it began working on while the drug was still in shortage

BMC Genomics 25, 404