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Fycompa®, an antiepileptic drug, has gained approval in China as an adjunctive therapy for primary generalized tonic-clonic seizures.
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Health Canada has issued 13May guidance regarding the preparation of regulatory submissions in formats other than eCTD, instructions for electronically filing these submissions
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The European Union (EU) Clinical Trials Regulation-No 536
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Introduction to CMC Compliance for Medical Devices 4 core and 5 elective
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Basaglar and Toujeo-Basaglar is approved for use in adults and children (ages 6 years and older)
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AstraZeneca has acknowledged that its vaccine may lead to clotting, but there\’s no need for panic among Covishield vaccine recipients in India.
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Module 5 clinical summary report regulatory submission
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