FDA Guidance Document

An FDA Guidance Document provides recommendations and instructions from the Food and Drug Administration to help manufacturers and researchers develop, test, and market products like drugs, medical devices, and foods. It explains regulatory expectations, best practices, and scientific standards to ensure safety, effectiveness, and quality. While guidance documents are not legally binding, following them helps companies meet regulatory requirements and streamline approval processes. Essentially, they serve as an official roadmap to ensure products are safe for consumers and compliant with federal regulations.