TGA-Submitting data in the eCTD format – TGA – Australia-2024
TGA-eCTD format Submitting data – Australia-2024 Submitting data in the eCTD format – TGA – Australia-2024 , The following guidance is intended for sponsors and …
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Fycompa®, an antiepileptic drug, has gained approval in China as an adjunctive therapy for primary generalized tonic-clonic seizures.
Fycompa®, an antiepileptic drug 13 May, has gained approval in China as an adjunctive therapy for primary generalized tonic-clonic seizures. Fycompa® Eisai Co., Ltd Fycompa® …
Health Canada has issued 13May guidance regarding the preparation of regulatory submissions in formats other than eCTD, instructions for electronically filing these submissions
Health Canada 13 may has issued guidance regarding the preparation of regulatory submissions in formats other than eCTD, instructions for electronically filing these submissions “Health …
The European Union (EU) Clinical Trials Regulation-No 536
The European Union (EU) Clinical Trials Regulation The European Union (EU) Clinical Trials Regulation (CTR) is a regulation that aims to simplify and harmonize the …
Introduction to CMC Compliance for Medical Devices 4 core and 5 elective
Introduction to CMC Compliance for Medical Devices Introduction to CMC (Chemistry, Manufacturing, and Controls) compliance is a critical factor in the development and approval of …
Regulatory affair eCTD compilations-4.0 list of regulatory affairs modules
Regulatory affair eCTD compilations eCTD compilations The electronic common technical document (eCTD) is a standard format for submitting regulatory affairs documentation to regulatory authorities such …
eCTD Regulatory affair & ICH-GCP-V4.0
eCTD Regulatory affair & ICH-GCP eCTD Regulatory affair & ICH-GCP Regulatory affairs is a critical component of clinical research and drug development, as it involves …
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 …
Module 5 clinical summary report regulatory submission
Module 5 clinical summary report regulatory submission module 5 on clinical summary reports. Module 5 clinical summary report regulatory submission , A clinical summary report …