Zdrowie i gospodarka · 25/04/2012

FDA Releases Draft Guidance on Assessing Effects of Manufacturing Process Changes on Food Safety and Regulatory Status

The Food and Drug Administration (FDA) has released a draft guidance document that outlines its approach to assessing the impact of significant manufacturing process changes, including emerging technologies, on the safety and regulatory status of food ingredients and substances. The document aims to clarify the factors to be considered when determining whether changes in manufacturing process warrant a new regulatory submission to the FDA.