Tag: FDA

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 Regulatory News – Feb. 2024

March 6, 2024
Consumer Health

USA New Directory of Ingredients Used in Products Marketed as Dietary Supplements The U.S. Food and Drug Administration (FDA) has updated the agency’s Ingredient Directory, including renaming...

Asia Health, BPA, Consumer Health News, Dietary Supplements, EUHealth, FDA, February2024, Global Health, Health Regulations, Healthcare News, Medical Guidelines, Regulatory Updates

Consumer Health USA/Asia/ROW Regulatory News – Jan 2024

February 8, 2024
Consumer Health

USA FDA announces availability of Additional Submission Tools for Cosmetic Facility Registration and Product Listing The U.S. Food and Drug Administration (FDA) officially launched additional...

Asia Regulations, Consumer Health, FDA, Regulatory Updates, ROW Imports