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Home » FDA to Generic Firms: Comply With USP’s Residual Solvents Rule
FDA to Generic Firms: Comply With USP’s Residual Solvents Rule
August 19, 2008
Makers of generic drugs with pending ANDAs must amend their applications to include changes required by a revised U.S. Pharmacopeia (USP) monograph on residual solvents “as soon as possible,” the FDA says in a draft guidance.