TGA-Submitting data in the eCTD format – TGA – Australia-2024
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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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Regulatory affair eCTD compilations-4.0 list of regulatory affairs modules
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CMC regulatory affairs: An introduction to CMC and compliance V5.0
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eCTD Regulatory affair & ICH-GCP-V4.0
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Basaglar and Toujeo-Basaglar is approved for use in adults and children (ages 6 years and older)
Basaglar and Toujeo are both long-acting insulin formulations used to treat diabetes. Basaglar is a long-acting insulin-Basaglar and Toujeo Basaglar is a long-acting insulin that …
AstraZeneca has acknowledged that its vaccine may lead to clotting, but there’s no need for panic among Covishield vaccine recipients in India.
AstraZeneca has acknowledged that its vaccine may lead to clotting, but there’s no need for panic among Covishield vaccine recipients in India. AstraZeneca has acknowledged …