Newsletter - April 11, 2024
Can FDA Approval Be Reversed by Public Opinion?
A genetic diagnostic test approved by the FDA has come under surprisingly strong criticism by researchers, physicians, and some public interest groups, so much so that they have petitioned the FDA to revoke its approval and that CMS should not cover it. But would the FDA rescind a test it approved based...Read More
FDA Registration of New Dietary Ingredients Detailed
New Dietary Ingredient (NDI) registration has been required for almost 30 years but the regulations for such registration are one of the hardest to enforce and frequently less understood. There are many perceptions, right or wrong, about the definition of an NDI, the contents of the application for registration...Read More
Can FDA Approval Be Reversed by Public Opinion?
A genetic diagnostic test approved by the FDA has come under surprisingly strong criticism by researchers, physicians, and some public interest groups, so much so that they have petitioned the FDA to revoke its approval and that CMS should not cover it. But would the FDA rescind a test it approved based...Read More
FDA Registration of New Dietary Ingredients Detailed
New Dietary Ingredient (NDI) registration has been required for almost 30 years but the regulations for such registration are one of the hardest to enforce and frequently less understood. There are many perceptions, right or wrong, about the definition of an NDI, the contents of the application for registration...Read More
