The US FDA grants priority review to Mercks sBLA for Keytruda with chemo for metastatic malignant pleural mesothelioma. The US FDA grants priority review to Mercks sBLA for Keytruda with chemo for metastatic malignant...
News Articles / Regulatory affairs
by samitfm · Published May 24, 2024 · Last modified December 30, 2024
EU IDMP Implementation Guide -2 Data elements for the electronic submission of information on medicinal products for human use EU IDMP Implementation Guide -2_Data elements for the electronic submission of information on medicinal products...
News Articles / Regulatory affairs
by samitfm · Published May 24, 2024 · Last modified January 8, 2025
Certification of suitability:New requirements for CEP to the Monographs of the European Pharmacopoeia CEP dossier 2.0 New requirements for the content of the CEP dossier for chemical purity and for herbal drugs/herbal drug preparations...
News Articles / Regulatory affairs
by samitfm · Published May 23, 2024 · Last modified January 8, 2025
TGA-eCTD format Submitting data – Australia-2024 Submitting data in the eCTD format – TGA – Australia-2024 , The following guidance is intended for sponsors and manufacturers interested in submitting data in the electronic Common...
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® antiepileptic drug Eisai Co., Ltd., headquartered in Tokyo and...
News Articles / Regulatory affairs
by samitfm · Published May 15, 2024 · Last modified January 8, 2025
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 Canada has issued guidance regarding the preparation of regulatory...
News Articles / Regulatory affairs
by samitfm · Published May 11, 2024 · Last modified January 8, 2025
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 clinical trial approval process in the EU. The CTR...
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 medical devices. The CMC regulatory framework ensures that medical...
News Articles / Regulatory affairs
by samitfm · Published May 10, 2024 · Last modified January 8, 2025
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 as the US Food and Drug Administration (FDA) and...
CMC regulatory affairs: An introduction to CMC and compliance CMC regulatory affairs CMC Regulatory affairs is an important component of the development and approval of pharmaceutical and medical device products. The process of regulatory...
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