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Top Industry News
- Swissmedic Updated Requirements for Dealing With Possible Nitrosamine Impurities in Pharmaceutical Products
- FDA Guidance on Human Gene Therapy Products Incorporating Human Genome Editing
- Swissmedic - Voluntary Advance Notice of New Registrations With New Active Substances
- EMA - Clinical Trials Transition to New EU System - One Year Left
- EC Guidance - MDCG Endorsed Documents and Other Guidance
- FDA Draft Guidance on Conducting Remote Regulatory Assessments Questions and Answers
- MHRA Announces Two New UK Approved Bodies to Certify Medical Devices
- SFDA Guidance for Points of Care (POC) Medical Devices Manufacturing
- MDA Second Edition Guidance Document MDA/GD/0005: General Medical Device - Grouping
- FDA CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk IVDs
- MDA First Edition Guidance Document MDA/GD/0067: Post Market Information Exchange for ASEAN Member States
- EFSA has Released a Safety Assessment for Isomaltulose Syrup (dried) as a Novel Food in Accordance with Regulation (EU) 2015/2283.
- AICIS Australia Published the Latest Inventory Snapshot: Download Now
- Cosmetics Europe's Expert Team Ingredient Monitoring and Assessment (ET IMA) is Monitoring Cosmetic Ingredients Undergoing Regulatory Processes That Could Impact Their Use in Cosmetic Products
- The EU Commission has Notified the World Trade Organisation (WTO) about the 22nd Adaptation to Technical Progress (ATP) to the EU Classification, Labelling and Packaging Regulation, Which is Open for 60 Days of Comments
- MDA First Edition Guidance Document MDA/GD/0066: Importation of Medical Device for Personal Use
- Director Resolution Nº 023-2023-INACAL/DN Peruvian Technical Standards on Granadilla, Rice, and Others are Approved
- AICIS Added A List of Chemicals Added to the Inventory 5 Years After Issue of Assessment Certificate
Mergers & Acquisitions
- Oxford Biomedica Completes Acquisition of ABL Europe
- Carmot Therapeutics Announces Completion of Acquisition by Roche
- AVROBIO and Tectonic Therapeutic Announce Merger
- Aditxt, Inc. Acquires Proprietary Electroencephalography (EEG) Brain Monitoring Technologies and Devices, Including NeuroCap(TM) and NeuroEEG(TM) for Telehealth and Tele-neurology Applications
- RTI Surgical Completes Acquisition of Cook Biotech