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Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance By Zachary Brennan - Published 08 August 2017

With an increased demand for the repackaging of solid oral dosage form drugs into unit-dose containers, the US Food and Drug Administration (FDA) on Tuesday released revised draft guidance on the conditions under which it does not intend to take action regarding stability studies and the expiration date to assign.

Categories: News, US, FDA, Drugs, Packaging, Regulatory intelligence, Regulatory strategy

Tags: expiration date, FDA draft guidance, repackaging