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FDA Guidelines

Meaning

The set of authoritative, legally binding regulations, recommendations, and standards issued by the U.S. Food and Drug Administration (FDA) that govern the research, development, manufacturing, labeling, and marketing of pharmaceuticals, medical devices, and certain food products. In the hormonal health sphere, these guidelines ensure that hormone therapies, supplements, and related diagnostic tools meet rigorous standards for safety and demonstrated efficacy before they can be legally made available to the public. Adherence to these protocols is mandatory for all companies operating within the regulated space.