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May 11, 20221 min read

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Earlier on 9-May-2022, FDA announced that a draft guidance document was available to assist the industry regarding the Benefit-Risk...

Jul 29, 20211 min read

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...