Top Industry News
- EMA- Updated Reminder on the Working Documents Provided Within the eCTD Submissions
- TGA- GMP Clearance Applications Using Health Canada Evidence
- Health Canada and United States Food and Drug Administration Joint Public Consultation on the ICH of Technical Requirements for Pharmaceuticals for Human Use Guidelines Update
- SAHPRA- Safety Reporting During Clinical Trials - Guideline Document
- MHRA- Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) including Pharmacovigilance System Master Files (PSMF) in a No-Deal Brexit
- TGA Issues Guidance on Patient Implant Cards, Information Leaflets
- EMA- What’s New in Pharmacovigilance - QPPV Update - Issue 1 - 2019
- FDA Reports on Status of Postmarketing Requirements and Commitments
- China Expands Medical Device Registration Pilot to Cover Multiple Regions
- EMA Clarifies Requirements for Peptones Used in Active Substance Manufacturing
Mergers & Acquisitions
- Bayer Acquires BlueRock Therapeutics to Build Leading Position in Cell Therapy
- Nucleus Biologics Acquires Primorigen Biosciences
- Neoleukin Therapeutics and Aquinox Pharmaceuticals Complete Merger Transaction
- ZYUS Life Sciences to Acquire Revon Systems
- Vesselon Acquires FDA-Approved Lipid Microsphere Drug Imagent® For Therapeutic Platform
- Glaukos and Avedro Announce Definitive Acquisition Agreement