Month: May 2024

The DCGI underscores the necessity of performing sample tests to verify that medical devices and in-vitro diagnostics (IVDs) comply with established standards-2024

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The DCGI underscores the necessity of performing sample tests to verify that medical devices and in-vitro diagnostics (IVDs) comply with established standards. DCGI medical devices and in-vitro diagnostics (IVDs) DCGI medical devices and in-vitro diagnostics (IVDs) Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), has stressed the importance of ensuring that medical …

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CDSCO has issued a revised edition of its guidance document pertaining to biologicals.

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CDSCO has issued a revised edition of its guidance document pertaining to biologicals. CDSCO has issued a revised edition of its guidance document pertaining to biologicals. The Central Drugs Standard Control Organisation (CDSCO) has recently released an updated edition of the Guidance for Industry for Biologicals, marking the first revision in 16 years since the …

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The US FDA grants priority review to Mercks sBLA 2024 for Keytruda with chemo for metastatic malignant pleural mesothelioma.

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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 pleural mesothelioma. Merck, referred to as MSD outside the United States and Canada, has announced that the U.S. Food and Drug …

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EU IDMP Implementation Guide -2_Data elements for the electronic submission of information on medicinal products for human use

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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 for human use, The EMA released version 2.0 (EU IG v2.0) in February 2021. This version is primarily designed to assist …

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Certification of suitability : New requirements for CEP to the Monographs of the European Pharmacopoeia CEP dossier 2.0

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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 according to the CEP 2.0 Certification of suitability Submitting Active Pharmaceutical Ingredient (API) information to the European Directorate for the Quality …

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TGA-Submitting data in the eCTD format – TGA – Australia-2024

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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 Technical Document (eCTD) format for various types of products including prescription medicines, biological products, over-the-counter medicines, registered complementary medicines, assessed listed …

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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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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 led by CEO Haruo Naito, has announced the approval of an expanded indication for its internally developed antiepileptic drug (AED) Fycompa® …

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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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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 submissions in formats other than eCTD, instructions for electronically filing these submissions.\” Health Canada issued an updated guidance on May 13, …

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The European Union (EU) Clinical Trials Regulation-No 536

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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 replaces the previous Clinical Trials Directive and is expected to improve patient safety, increase transparency, and facilitate the conduct of clinical …

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Introduction to CMC Compliance for Medical Devices 4 core and 5 elective

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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 devices meet quality, safety, and efficacy standards before they are marketed for public use. CMC compliance guidelines are established by regulatory …

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