Draft Guidance

Draft Guidance is a preliminary document issued by a regulatory agency, like the FDA, to provide recommendations or direction on specific policies, procedures, or standards. It’s meant to gather feedback from stakeholders before finalizing the guidance, ensuring that the final version reflects practical input and addresses potential concerns. Essentially, it outlines recommended practices but is not legally binding until officially finalized, helping industry and regulators stay aligned on expectations and best practices during development or compliance processes.