Tag: Clinical Trials

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

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

Global Regulatory Intelligence

Standards

The health authority (HA) guidelines, policies, and laws governing the product registration, manufacturing, or licensing processes keep evolving and vary across markets. Establishing an effective regulatory...

Clinical Trials, Compliance Procedures, Health Authority, Manufacturing Requirements, Regulatory Intelligence