The DCGI underscores the necessity of performing sample tests to verify that medical devices and in-vitro diagnostics (IVDs) comply with established standards-2024
The DCGI underscores the necessity of performing sample tests to verify that medical devices and in-vitro diagnostics (IVDs) comply with…
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. CDSCO has issued a revised edition of…
The US FDA grants priority review to Mercks sBLA 2024 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. The US…
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 EU…
Certification of suitability : New requirements for CEP to the Monographs of the European Pharmacopoeia CEP dossier 2.0
Certification of suitability:New requirements for CEP to the Monographs of the European Pharmacopoeia CEP dossier 2.0 New requirements for the…
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…
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.…
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…
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…
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…