FDA Guidances

FDA guidances are official documents that provide recommendations to help companies develop, manufacture, and distribute healthcare products like drugs and medical devices. They serve as a roadmap, outlining best practices, regulatory expectations, and standards to ensure products are safe, effective, and of high quality. While not legally binding, following these guidances can facilitate approval processes, reduce risks, and promote consistency across the industry. Essentially, they help manufacturers and the FDA work together toward safe and reliable healthcare products for consumers.