Medical Foods > Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition:
"The responses to these FAQs address common questions about the definition of and regulations for medical foods. This guidance is a second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.” This guidance provides responses to additional questions regarding the definition, labeling, and availability of medical foods and updates to some of the existing responses; new questions and answers and amended responses are identified by the date they were added to the guidance."
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