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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Earlier on 9-May-2022, FDA announced that a draft guidance document was available to assist the industry regarding the Benefit-Risk...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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Guideline on Quality Documentation for Drug-Device Combination Products - EMA
The European Medicines Agency (EMA) on 22-July-2021 has adopted a guideline on the quality information that manufacturers of combination...

Sharan Murugan
Jul 29, 20211 min read
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