FDALaw Blog--December 18, 2013 Medical Food Draft Guidance – Has the FDA Bitten Off More than it Can Chew? By Riëtte van Laack & Wes Siegner –

Hyman, Phelps & McNamara, P.C. has filed comments to FDA’s Draft Guidance on Frequently Asked Questions about Medical Foods - Second Edition.  As discussed in a prior post, FDA’s Draft Guidance seeks to establish a policy with respect to medical foods that would eliminate medical foods as an FDA category for all but a very few products that, in FDA’s view, meet FDA’s criteria

continue to read here