FDA extends on 24 DSCSA tracking rules for small dispensers by two years and allows exemption requests.
DSCSA (Drug Supply Chain Security Act): FDA extends on 24 DSCSA tracking rules for small dispensers by two years and…
Regulatory Pharma Blogs
DSCSA (Drug Supply Chain Security Act): FDA extends on 24 DSCSA tracking rules for small dispensers by two years and…
Medical device equipment: The report suggests strategies to enhance accessibility and cost-effectiveness of crucial medical device equipment. Medical device equipment…
Device surveillance the European Unions Medical Device Coordination Group (MDCG) has released revised guidance on device surveillance. Device surveillance The…
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 New requirements for the…
TGA-eCTD format Submitting data – Australia-2024 Submitting data in the eCTD format – TGA – Australia-2024 , The following guidance…
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 The European Union (EU) Clinical Trials Regulation (CTR) is a regulation that aims…
Introduction to CMC Compliance for Medical Devices Introduction to CMC (Chemistry, Manufacturing, and Controls) compliance is a critical factor in…
Regulatory affair eCTD compilations eCTD compilations The electronic common technical document (eCTD) is a standard format for submitting regulatory affairs…