A recall has been issued for a batch of Depo-Medrone 80 mg in 2 mL vials…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Breaking News: GHWP Withdraws Membership from IMDRF
On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew from the International Medical…
FDA Emergency Authorization of Animal Drugs Tackles New World Screwworm Threat to Food Supply
The U.S. Department of Health and Human Services (HHS) announced a declaration enabling the Food and…
Urgent Recall of Batch-Specific Omeprazole Oral Solution Due to Quality Concerns
On October 2, 2025, Glenmark Pharmaceuticals Europe Ltd announced a precautionary recall of a specific batch…
FDA Introduces Daily Updates on Adverse Event Reporting for Drug Safety Insights
The U.S. Food and Drug Administration (FDA) has announced a major step forward in public health…
Tamoxifen 20mg Tablets Recall: Stability Testing Uncovers Dissolution Issue
Wockhardt UK Limited issued a precautionary recall of a batch of Tamoxifen 20mg film-coated tablets after…
FDA Demands Safer Nicotine Pouch Packaging Amid Rising Cases of Child Exposure
The U.S. Food and Drug Administration (FDA) has issued a strong appeal to nicotine pouch manufacturers,…
Urgent Notification: Superseded Patient Information in Erythromycin Stearate BP 250mg Tablet Batch
Amdipharm UK Ltd has reported a critical issue regarding a batch of Erythromycin Stearate BP 250mg…
FDA Introduces Groundbreaking Guidance to Streamline Rare Disease Drug Development
The U.S. Food and Drug Administration (FDA) has launched the Rare Disease Evidence Principles (RDEP) initiative,…
Critical Advisory: New Aurum 10ml CONNECT Syringe Barrel Requires Compatible Needle-Free Connectors to Prevent Blockages
Healthcare professionals are urged to adopt compatible needle-free connectors (NFCs) with the newly phased-in Aurum 10ml…