Tag: FDA

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

June 4, 2025
Medical Device

USA Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The aim of this guidance document is to outline the various mechanisms available...

Compliance, Digital Health, EU Regulations, FDA, Global Health, Healthcare Innovation, Med Tech, Medical Devices, Regulatory Affairs, UDI

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

Consumer Health – USA/UK/Asia/ROW Regulatory News – Feb 2025

March 12, 2025
Consumer Health

USA Outbreak Investigation of Listeria monocytogenes: Frozen Supplemental Shakes The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate...

Consumer Health, FDA, February 2025, Food Regulations, Food Safety, Global Health Compliance, Health Updates, Product Safety, Regulatory News

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