Regulatory Affairs

FDA Reacts to Florida’s Ban on 7-OH Opioid Products: What You Need to Know

Meta description: The FDA addresses Florida’s new restrictions on 7-OH opioid products, discussing implications for clinical and regulatory teams. Find…

Regulatory Alert: Recall of Kimmtrak 200 micrograms/mL Due to Potency Issues

Immunocore Limited is urgently recalling specific batches of its Kimmtrak 200 micrograms/mL concentrate for solution for infusion after stability testing…

IMDRF Launches Online Membership Forms: A Streamlined Submission Process

From May 2025, regulatory professionals and other stakeholders involved with medical device oversight will benefit from an important update. The…

FDA Greenlights Papzimeos: First Immunotherapy for Recurrent Respiratory Papillomatosis

On October 2, 2025, the U.S. Food and Drug Administration (FDA) announced the approval of Papzimeos, the first immunotherapy specifically…

Urgent Recall: Depo-Medrone Labeling Error Poses Dosage Risk

A recall has been issued for a batch of Depo-Medrone 80 mg in 2 mL vials due to a critical…

Breaking News: GHWP Withdraws Membership from IMDRF

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Urgent Notification: Superseded Patient Information in Erythromycin Stearate BP 250mg Tablet Batch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…