FDA Guidance Documents

FDA Guidance Documents are official communications from the U.S. Food and Drug Administration that provide detailed advice on how to comply with laws and regulations concerning the safety and effectiveness of drugs, medical devices, and food products. These documents outline best practices, regulatory expectations, and recommendations for manufacturers and researchers, helping them navigate the approval process. While they are not legally binding, following these guidelines can facilitate compliance and improve the quality of submissions to the FDA. Essentially, they help ensure that products meet safety standards for public health.