US Food and Drug Administration officials recently criticized independent third parties and drug product manufacturers for not using US Pharmacopeia compendial or comparable methods when testing drug product quality.
Speaking at the 18-20 September Parenteral Drug Association/FDA conference, they outlined why they believe organizations should not rely on such third-party quality testing, while recapping warning
Key Takeaways
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The FDA sees no need to independently test marketed drug products for quality.
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Any such testing should use compendial or comparable methods
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