Stability

29
Jul

Repackaging Product into Unit Dose Packaging and Stability Requirements – Final Guidance Issued

Today, the FDA finalized an older draft guidance from August 2017 on repackaging of solid oral dosage form product from original containers into unit dose packaging that provides firms the ability to do so without (in most cases) performing additional stability studies.  The Agency notes that it “received a few comments on the revised draft […]

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