Tag: Global Regulatory News

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2025

Medical Device

USA 1. Guidance on: Quality Management System Information for Certain Premarket Submission Reviews The guidance highlights the importance of submission of comprehensive, risk-based QMS documentation...

CDSCO India, EU MDR, FDA guidance, Global Regulatory News, MDA Malaysia, Medical Device Compliance, Medical Device Regulations, QMS, SaMD

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Sept 2025

Medical Device

USA Final Guidance: Computer Software Assurance FDA released its long-awaited final guidance on Computer Software Assurance (CSA), replacing Section 6 of the 2002 software validation guidance....

CSA software validation, eSTAR submissions, EU MDR, FDA guidance, Global Regulatory News, Health Canada, Medical Device Compliance, medical device cybersecurity, Medical Device Regulations, MHRA clinical investigations, TGA

Consumer Health – USA, Asia and ROW Regulatory News – June 2025

Consumer Health

USA FDA Releases 2025 Human Foods Program Guidance Agenda – June 30, 2025 The FDA’s Human Foods Program has published its proposed 2025 guidance agenda, outlining key topics it plans to address...

ANMAT FSSAI Updates, Asia Health Compliance, FDA Updates 2025, Food Safety Standards, Global Regulatory News, Health Product Recalls, June 2025 Health Alerts, ROW Compliance Changes

Consumer Health – USA, Europe, Asia and ROW Regulatory News – May 2025

Consumer Health

USA FDA Approves Three Natural Food Colors, Advancing Shift Away from Petroleum-Based Dyes On May 9, 2025, the FDA approved three new color additives – Galdieria extract blue, butterfly...

Anvisa cosmetic rules, Consumer health regulations, EU food compliance Asia regulatory intelligence, FDA health updates FSSAI food safety, Global Regulatory News, Health product regulations

Consumer Health – USA, UK, Asia and ROW Regulatory News – Aug 2024

Consumer Health

USA FDA Starts Next Phase of Sodium Reduction Efforts FDA took another important step in its sodium reduction efforts. The agency has issued new, voluntary targets for sodium reduction in foods...

FDA News, Food Regulations, Food Safety, FSSAI, Global Regulatory News, Health News, Regulatory Updates