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What are the regulatory requirements for genotoxicity assessment

Lukacs, A., Tonge, P

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Pregnancy and lactation represent relative contraindications given absence of human safety data in these populations despite reassuring preclinical reproductive toxicology studies

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The FDA's Pharmacy Compounding Advisory Committee will meet on Wednesday and Thursday to consider if seven peptides should be added to the agency's 503A Bulks List, a step that would permit state-licensed compounding pharmacies to prepare the substances for patients with prescriptions