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USFDA Guidance - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
USFDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production"....

Sharan Murugan
May 17, 20221 min read
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USFDA Guidance on Product Quality Assessments - Benefit-Risk Considerations
Earlier on 9-May-2022, FDA announced that a draft guidance document was available to assist the industry regarding the Benefit-Risk...

Sharan Murugan
May 11, 20221 min read
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