Day: August 18, 2016

This week FDA announced the final rule for determining the “Generally Recognized as Safe” (GRAS) status of food ingredients. The new process replaces the current process of petitioning FDA to affirm the GRAS status, with a voluntary notification about a conclusion that a substance is GRAS under the conditions of its intended use in human food or … Read more

It is critical that a product be properly classified as a drug or medical device. For products where a clear unambiguous scientifically justifiable classification as a drug or medical device cannot be made, the developer are required to make a Request for Designation (RFD) with the Office of Combination Products (OCP) at the FDA. Classification of a given product … Read more