Tag: Regulatory Updates

Consumer Health – USA, S America, Asia and ROW Regulatory News – Mar 2025

April 17, 2025
Consumer Health

USA HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families Under the leadership of HHS Secretary Robert F. Kennedy...

ANMAT, BPOM, COFEPRIS, Consumer Health, FDA, Food Safety, FSANZ, Healthcare Compliance, March2025, Regulatory Updates

Regulatory Intelligence Database, Software & Tools for Compliance

March 19, 2025
Regulatory Intelligence

What is Regulatory Intelligence? Regulatory Intelligence (RI) is the process of collecting, analysing, and interpreting regulatory information to help organizations comply with legal and industry...

Compliance Software, Medical Device Regulations, Pharma Compliance, Reg Tech, Regulatory Affairs, Regulatory Compliance, Regulatory Intelligence, Regulatory Technology, Regulatory Updates

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

March 11, 2025
Medical Device

USA Guidance on Institutional Review Board (IRB) Written Procedures The FDA and HHS OHRP have jointly issued the final guidance on Institutional Review Board (IRB) Written Procedures to enhance...

Asia Regulations, Europe Regulations, Global Regulatory, Healthcare Regulations, Med Tech Updates, Medical Device News, Medical Devices, Regulatory Updates, ROW Regulatory, USA Regulations

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

February 6, 2025
Medical Device

USA Guidance on Premarket Approval Application and Humanitarian Device Exemption Modular Review The guidance provides information on the Premarket Approval Application (PMA) and Humanitarian...

Device Approval, EU Regulations, FDA, Global Regulations, Healthcare Regulations, Innovation Healthcare, MDR2025, Medical Device, Medical Device Compliance, Medical Device Industry, Regulatory Affairs, Regulatory News, Regulatory Updates

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Jan 2025

February 5, 2025
Biopharma

USA FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain The U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class...

BioPharma, BioTech, Clinical Trials, Drug Approval, EMA, FDA, Healthcare Pharma Regulations, Pharma News, Regulatory Updates

Consumer Health – USA/Europe/Asia/ROW Regulatory News – Jan 2025

February 5, 2025
Consumer Health

USA FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods The U.S. Food and Drug Administration is announcing an important step to provide nutrition information...

Consumer Health, FDA, Food Safety, Global Health, Healthcare News, Medical Compliance, Nutrition Labels, Public Health, Regulatory Updates, Tobacco Regulations