Draft Guidance for Industry and Review Staff on Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled "Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route." The draft guidance provides recommendations concerning development of safety profiles to support approval of reformulated drug products and products proposed for use by a route of administration for which the product was not previously approved.