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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

Consumer Health – USA/Europe/Asia/ROW Regulatory News – June 2024

July 4, 2024
Consumer Health

USA Constituent Updates: FDA Proposes to Exempt Certain Cottage Cheese from Traceability Requirements The Food Traceability Rule establishes additional recordkeeping requirements, beyond...

Consumer Safety, Cottage Cheese, FDA, Food Allergens, Food Regulation, Food Safety, Food Standards, Health Warning, Public Health, Traceability

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

Consumer Health – USA/Europe/Asia/ROW Regulatory News – May 2024

June 19, 2024
Consumer Health

USA Infant Formula Many infants in the U.S. rely on infant formula for some or all of their nutrition. Ensuring that the youngest and most vulnerable individuals have access to safe and nutritionally...

Consumer Health, Consumer Protection, Food Quality, Food Regulations, Food Safety, Food Safety News, Health And Safety, Health News, Health Policy, Health Regulations, Health Standards, May2024, Public Health, Regulatory Updates, Safety Efforts

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