Regulatory Affairs

Global updates on medical device regulation and quality.

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441 articles in Regulatory Affairs
Europe

Swissmedic Authorizes Temporary Distribution of Xenpozyme in Taiwanese Packaging

On January 10, 2026, Swissmedic announced the temporary authorization for the distribution of Xenpozyme Pulver zur Herstellung einer Lösung zur…

Europe

Swissmedic Highlights Medication Mix-Up: Phosphonorm® Erroneously Administered Instead of Phoscap

In a recent pharmacovigilance update dated January 10, 2026, Swissmedic reported an important issue regarding a specific medication mix-up involving…

Europe

Swissmedic Opens Recruitment for Product Owner Role in Regulatory Operations

Swissmedic, the Swiss agency responsible for therapeutic products, is seeking a Product Owner to join its Operational Support Services division.…

Europe

Swissmedic Offers Targeted GMP/GDP Consultations for Regulatory Clarity

On January 10, 2026, Swissmedic announced a dedicated platform for addressing specific questions related to Good Manufacturing Practices (GMP) and…

Europe

Swissmedic Approves Temporary Distribution of Enrylaze 10 mg Injection in Select EU Packaging

Swissmedic has granted a temporary authorization for the distribution of Enrylaze 10 mg/vial injection solution in distinct packaging formats from…

Europe

Swissmedic Issues Recall of Locametz 25 mcg Multidose Kits for Radiopharmaceutical Use

Swissmedic has announced a precautionary recall of specific batches of Locametz 25 mcg Multidose Kits for radiopharmaceutical applications. Clinical teams,…

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FDA Alert: Nationwide Recall of Rheumacare Capsules Due to Dangerous Lead Levels

On January 10, 2026, Handelnine Global Limited, operating under the trade name Navafresh, announced a nationwide recall of their Rheumacare…

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Federal Alert: Gold Star Distribution Recalls FDA-Regulated Products Citing Severe Contamination Risks

On December 26, 2025, Gold Star Distribution, Inc. issued a recall of multiple FDA-regulated products in response to serious contamination…

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Primavera Nueva Inc. Expands Recall of Tamales Due to Potential Listeria Risk: Updated Details You Need to Know

Primavera Nueva Inc., a Sonoma, California-based company, has announced an expanded voluntary recall of selected lots of its 4-count tamales…

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Carrot Top Kitchens Recalls Hummus Over Undeclared Sesame Risk

On January 10, 2026, Carrot Top Kitchens LLC, operating in Bridgeport, Connecticut (formerly Redding), issued a Class II recall for…

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Modern Warrior’s “Ready” Supplement Recall: Undeclared 1,4-DMAA, Aniracetam, and Unapproved Tianeptine Identified by FDA

[Phoenix, Arizona] – On December 22, 2025, Modern Warrior voluntarily announced a nationwide recall of all lots of its dietary…

Europe

Swissmedic Expands Therapeutic Indication for Ryeqo®

On 17 December 2025, Swissmedic announced an important regulatory update concerning the medication Ryeqo®. The approval marks an extension of…

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