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FDA Guidance

Meaning

FDA Guidance refers to official documents issued by the U.S. Food and Drug Administration that articulate the agency’s current thinking, policy positions, or expectations on a particular regulatory topic, such as drug development, clinical trials, or the appropriate use of specific medications. These documents are not legally binding regulations but represent the agency’s best advice and are critical for the pharmaceutical and clinical community to understand how the FDA interprets and enforces the law. Clinicians and researchers often rely on FDA guidance to ensure their practices, particularly in emerging fields like peptide therapy or hormone optimization, align with federal regulatory perspectives.