FDA Extends Time for Comments on Medical Foods Draft Guidance
The Food and Drug Administration is reopening the comment period for another 30 days on its proposed update to a guidance document on medical foods. Topics covered by the draft guidance include the definition of medical foods and labeling requirements…
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(including a prohibition on use of “Rx only” on medical foods labels) (see [Ref 13081522]). Comments were originally due Oct. 15. Industry had requested an extension of 60 days, but FDA said a shorter extension is sufficient because much of the frequently asked questions document is unchanged from a 2007 guidance. Comments are now due Dec. 16.