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In doing so, the agency could establish a consistent understanding of the compliance requirements imposed by a series of regulatory and legislative documents and updates
Trials will need to follow endocrine shifts, reproductive results, and off-target implications for years, not weeks
Jean-Martin Charcot
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Antivir Res
the study physician attributed the death to pre-existing coronary artery disease unrelated to the drug, but the FDA's Pharmacy Compounding Advisory Committee cited this "unresolved cardiac signal" in December 2024 as a reason to keep the compound off the approved compounding list
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