CRN comments on FDA's recently issued Draft Guidance

CRN applauds the Food and Drug Administration (FDA) for developing the Draft Guidance for Industry on Investigational New Drug Applications, which provides clarity in some areas.

CRN applauds the Food and Drug Administration (FDA) for developing the Draft Guidance for Industry on Investigational New Drug Applications, which provides clarity in some areas, including the important distinction that the clinical investigation of a dietary supplement for a structure/function endpoint does not require an Investigational New Drug Application (IND).

Read the CRN's complete comments [PDF]

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