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FDA-Approved Hormones

Meaning

FDA-approved hormones are specific pharmaceutical hormonal substances, which may be bioidentical or synthetic, that have successfully completed the rigorous scientific review process of the United States Food and Drug Administration for defined therapeutic indications. This official approval confirms that the hormone’s demonstrated benefits significantly outweigh its known risks for the intended patient population, based on comprehensive scientific evidence from controlled clinical trials. These approved products are manufactured under strict Current Good Manufacturing Practice (cGMP) guidelines, which guarantees their purity, potency, and consistent dosing.