Author name: Dr. Hatem Rabeh

On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew from the International Medical Device Regulators Forum (IMDRF), […]

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 Drug Administration (FDA) to

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 of its Omeprazole 20

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 transparency by initiating daily

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 stability testing revealed a

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, urging them to adopt

Urgent Notification: Superseded Patient Information in Erythromycin Stearate BP 250mg Tablet Batch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 tablets. The Patient Information

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, promising faster and more

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 CONNECT syringe barrels. This

Critical Update: Barcode Error Identified in Simvastatin 10mg From Crescent Pharma