Libre Duo FDA Authorisation Through De Novo Pathway
Abbott’s Libre Duo FDA authorisation creates a new Class II device category, combining glucose and ketone monitoring while setting a regulatory path for future devices.
Regulatory & IP
Mitigation of PFAS Contamination in Pharma Manufacturing
PFAS contamination is a growing manufacturing risk. Explore the latest on the research, wastewater challenges, monitoring, remediation, and pharma implications.
FDA 10 Guiding Principles of Good AI Practice in Drug Development
Get to know the FDA 10 Guiding Principles of Good AI Practice in Drug Development and what they mean for AI governance, validation, and regulatory risk.
LLMs in Clinical Trial Screening: Can AI Find the Right Patients?
Explore how LLMs in clinical trial screening could improve patient matching, and why human oversight, data quality, and trust remain essential.
Co-ordinated EU GMP Inspection Guidelines: What You Need to Know
New EU GMP inspection guidelines take effect in September 2026. Here is what you need to know about joint inspections, planning, and reporting.
World’s First Live AI-Assisted Brain Surgery
In the world’s first, London surgeons have used real-time AI to protect a patient's sight during live brain surgery. See what the trial’s AI framework means for MedTech.
The Strategic Role of CDMOs in Pharma Manufacturing
CDMOs in pharmaceutical manufacturing are becoming strategic partners, providing technical expertise, capacity, technology, and quality oversight.
FDA Clinical Trial Oversight Tightens Globally
FDA clinical trial oversight is intensifying globally as the agency raises expectations for GCP, foreign site inspections, data integrity, and patient protection.
Digital Health Technologies in Clinical Drug Development
Digital health technologies in clinical drug development need more than data. Explore validation, standards, digital endpoints, patient value, and regulation.
What Sponsors Need to Know About UK Combined Review 2026
UK Combined Review unifies MHRA and ethics review for CTIMPs, reshaping approval timelines, submissions, and sponsor planning under UK trial reform.
Ketryx and Accenture Build Regulated AI MedTech at Scale
Ketryx and Accenture are combining AI-native compliance infrastructure and transformation expertise to help MedTech scale regulated AI without slowing development.
Why Formulation Development Now Starts With Manufacturing
Formulation development is moving beyond drug delivery to shape manufacturing, quality, scale-up, and supply resilience across modern pharmaceutical operations.
