Business · 07/03/2008Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance on Safety Evaluation of Reformulated Drug Products
Summary
The Food and Drug Administration (FDA) has made available a draft guidance document outlining recommendations for the nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route, in support of potential FDA approval.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →