Tag: Global Health

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

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Sept 2024

October 7, 2024
Biopharma

USA FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia The U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral...

Asia Regulations, Drug Approvals, EMA, Europe Pharma, FDA, Global Health, Safety Updates, USA Drug Updates

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – June 2024

July 8, 2024
Biopharma

USA FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test The U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress...

Biotech Updates, Clinical Trials, Drug Safety, EMA, FDA, Global Health, Healthcare Regulations, Medical Devices, Pharma News, Regulatory News

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

July 4, 2024
Medical Device

USA Guidance on Laboratory Developed Tests: Small Entity Compliance Guide FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests”...

.Device Regulation, Compliance, EU, FDA, Global Health, Guidance, Health Care, June2024, Med Tech, Medical Devices, Regulatory News

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – May 2024

June 19, 2024
Biopharma

USA EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology In response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable,...

Bio Pharma, Bio Tech, Biotech News, Biotechnology, Drug Approval, EMA, FDA, Global Health, Health News, Healthcare, Healthcare Innovation, Medical Updates, Pharma Industry, Pharma News, Pharma Regulations, Pharma Trends, Pharma2024, Pharmaceuticals, Regulatory Updates

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

June 5, 2024
Medical Device

USA Remanufacturing of Medical Devices- Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff The guidance is intended to help clarify...

Compliance, eCTD, Global Health, Health Policy, IVDs, Medical Devices, Medical Technology, Regulations, Regulatory Updates