Tag: Regulatory Updates

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2024

November 6, 2024
Medical Device

USA Guidance on Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development The guidance provides a framework for determining whether, and what...

Asia Medical News, EU Regulations, Global Compliance, Healthcare Standards, Medical Device News, Medical Devices, Regulatory Updates, USA Medical Regulations

Consumer Health – USA/UK/Asia/ROW Regulatory News – Oct 2024

November 6, 2024
Consumer Health

USA Outbreak Investigation of E. coli O157:H7: Onions (October 2024) FDA is investigating slivered onions served at McDonald’s as the likely source of this outbreak. Onions have been recalled...

AsiaNews, Consumer Health, Food Safety, Global Health, Health Alerts, Health News, Public Health, Regulatory Updates, UK News, USA News

Key Features to Consider in Regulatory Intelligence Software for 2025

November 4, 2024
Regulatory Intelligence

The regulatory landscape is changing rapidly, and this has been rising challenges for businesses in terms of compliance across different jurisdictions. Tracking, analyzing, and compliance with the...

AI in Compliance, Business Compliance, Compliance Software, Data Driven Compliance, Global Compliance, Machine Learning, RegTech2025, Regulatory Intelligence, Regulatory Updates, Risk management

Medical Device Regulatory Challenges & Solutions | Expert Insights

September 13, 2024
Medical Device

Medical devices must meet stringent regulatory requirements to ensure safety and efficacy. These regulations are crucial but can also be complex and challenging for companies. Understanding and addressing...

Compliance Services, Device Compliance, Global Regulations, Medical Device Regulation, Regulatory Challenges, Regulatory Experts, Regulatory Solutions, Regulatory Strategy, Regulatory Updates

Pharma/Biotech – USA, UK, Asia and ROW Regulatory News – Aug 2024

September 5, 2024
Biopharma

USA FDA Approves First Nasal Spray for Treatment of Anaphylaxis The U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions...

COVID19 Vaccines, Drug Updates, FDA Approvals, Healthcare News, Medical News, Overdose Treatment, Pharma Updates, Regulatory News, Regulatory Updates

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Aug 2024

September 4, 2024
Medical Device

USA Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers The VMSR (Voluntary Malfunction Summary Reporting) Program allows device manufacturers to report certain device...

Asia Regulations, Europe Regulations, Global Compliance, Global Regulatory Updates, Healthcare Regulations, Medical Device Regulations, Medical Devices, Regulatory Updates, USA Regulations