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The Center for Drug Evaluation and Research (CDER) warning letters jumped 50% in fiscal year 2025

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The amount of diluent you add directly determines the final concentration of the peptide per unit of volume (e.g., milligrams per milliliter)

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In certain embodiments, tonicity agents are added to the formulations described herein in an amount as to provide a practical osmolality of an otic formulation of about 100 mOsm/kg to about 1000 mOsm/kg, from about 200 mOsm/kg to about 800 mOsm/kg, from about 250 mOsm/kg to about 500 mOsm/kg, from about 250 mOsm/kg to about 350 mOsm/kg, or from about 280 mOsm/kg to about 320 mOsm/kg