Regulatory Affairs

Urgent FDA Recall: Serious Safety Risks Linked to Bard PowerPICC Catheters

The FDA has issued an urgent recall for specific Bard PowerPICC Intravascular Catheters. Healthcare providers and regulatory teams are alerted…

Critical FDA Alert: AVID Medical Updates on Organ Recovery Kits to Address Safety Risks

The U.S. Food and Drug Administration (FDA) has issued a critical alert concerning Organ Recovery Packs and Medical Convenience Kits…

Nationwide Recall of Silintan Capsules Due to Undeclared Meloxicam: Safety Risks Highlighted

An urgent recall has been issued for Silintan capsules by Anthony Trinh, 123Herbals LLC, following FDA confirmation that the product…

Modern Warrior Ready Dietary Supplement Recalled for Undeclared and Unsafe Ingredients

On January 10, 2026, the U.S. Food and Drug Administration (FDA) announced an urgent recall of “Modern Warrior Ready,” a…

Regulatory Update: Swissmedic Expands Therapeutic Indication for Jaypirca®

Swissmedic has announced an extension of the therapeutic indication for Jaypirca®, a development that could impact clinical practice and regulatory…

Swissmedic Announces Recall of Ringerfundin B. Braun Batch Due to Quality Issues

On January 10, 2026, Swissmedic issued an official recall notice regarding specific batches of Ringerfundin B. Braun Infusionslösung. This recall…

Swissmedic Announces Recall of Specific Batches of Esomeprazol MUT Sandoz Tablets

On January 10, 2026, Swissmedic issued an announcement concerning the recall of designated batches of Esomeprazol MUT Sandoz gastro-resistant tablets.…

Swissmedic Expands Therapeutic Indication Approval for Pemazyre®

Swissmedic, the Swiss agency responsible for the authorisation and supervision of therapeutic products, recently approved an extension for the therapeutic…

Temporary Approval for Sevelamer Carbonate 800 mg Tablets in German Packaging

Swissmedic has issued a temporary marketing authorization for Sevelamercarbonate Salmon Pharma 800 mg film-coated tablets in German packaging. This development…

Swissmedic Announces Paper Leaflet Alternatives for Veterinary Medicines Starting 2026

Swissmedic has announced a significant change in packaging requirements for certain veterinary medicinal products. Starting January 1, 2026, it will…

European Pharmacopoeia 12.1 Enforcement Date Announced: Key Implications for Compliance

On January 1, 2026, the European Pharmacopoeia version 12.1 officially comes into force. Regulatory professionals, quality assurance teams, and clinical…

Revised Annex 7 TPLRO Variations Take Effect February 2026

A key regulatory development for the healthcare sector is set to take place early next year. A revised list of…