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FDA Peptide Guidance

Meaning

FDA Peptide Guidance refers to official regulatory documents and recommendations issued by the U.S. Food and Drug Administration that outline the agency’s current thinking on the development, manufacturing, and clinical evaluation of peptide drugs. This guidance addresses critical areas such as quality control, purity standards, non-clinical toxicology testing, and rigorous clinical trial design for these specific therapeutic agents. Adherence to this guidance is mandatory for obtaining regulatory approval for new peptide medications used in hormonal health.