Regulatory Compliance
Page 1 • 12 itemsNavigate global pharma regulatory compliance. Get critical intelligence on FDA, EMA, and global health authority updates for your business strategy.
ROIS Expands to US Market as Global CDMO with FDA Approval for Injectable Drug Manufacturing
ROIS establishes US operations as global CDMO with FDA, EMA, and other major regulatory approvals for end-to-end injectable drug manufacturing services.
ImmunityBio Faces Securities Fraud Lawsuit Over Anktiva Off-Label Promotion After FDA Warning Letter
ImmunityBio hit with class action lawsuit after FDA determined company made false claims about Anktiva bladder cancer drug's capabilities beyond approved use.
TGA Updates Comprehensive Regulatory Framework for Implantable Medical Devices in Australia
Australia's TGA provides updated guidance on implantable medical device regulations, covering manufacturing, application processes, and market authorization requirements.
PMDA Advances Japanese Pharmacopoeia and Medical Device Standards Development Through Enhanced Regulatory Science Framework
Japan's PMDA strengthens pharmaceutical and medical device standards through expanded regulatory science initiatives and Japanese Pharmacopoeia updates.
Australia's TGA Updates Personalised Medical Device Regulations: New Guidance for Market Authorization and Supply Chain Compliance
Australia's TGA releases comprehensive regulatory guidance for personalised medical devices, covering application processes, market authorization, and supply chain requirements.
RFID Technology Market to Reach $15 Billion by 2032, Transforming Pharmaceutical Supply Chain Management
RFID tags market projected to hit $15 billion by 2032, driven by pharmaceutical serialization mandates and IoT integration for enhanced drug tracking.
WuXi Biologics Receives South Korea GMP Certification for Bispecific Antibody Manufacturing
WuXi Biologics secures South Korea MFDS GMP certification for three facilities, enabling commercial manufacturing of bispecific antibody therapeutics.
Australia's TGA Updates In Vitro Diagnostic Device Regulations for Medical Device Manufacturers
Australia's Therapeutic Goods Administration releases comprehensive guidance for in vitro diagnostic device manufacturing, applications, and market authorization.
Mabwell Bioscience Passes First PIC/S Member GMP Inspection for Denosumab Biosimilars in Jordan
Mabwell Bioscience achieves milestone regulatory approval as Jordan FDA clears GMP inspection for two denosumab biosimilars, expanding global reach.
Mabwell Subsidiary T-mab Passes Jordan GMP Inspection for Denosumab Biosimilars
Mabwell's T-mab subsidiary receives GMP compliance approval from Jordan FDA for two denosumab biosimilars, marking regulatory milestone for bone treatments.
TGA Updates Medical Device Regulations for AI and Software-Based Therapeutic Products in Australia
Australia's TGA provides comprehensive regulatory guidance for medical devices including AI and software products through ARTG registration and manufacturing standards.
WuXi Biologics Achieves ISO 13485 Certification for Drug-Device Combination Products Manufacturing
WuXi Biologics becomes first in China to achieve ISO 13485:2016 certification with zero non-conformities for drug-device combination product development.