FDA Issues Warning on Elevated Risk of Device Failure for Hintermann Series H3 Total Ankle Replacement
The U.S. Food and Drug Administration (FDA) has released an updated safety communication regarding the Hintermann Series H3 Total Ankle…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Latest News
Europe
Swissmedic Grants Initial Authorisation for Filsuvez®: A Key Milestone in Advanced Therapies
Swissmedic, the Swiss agency for therapeutic products, has announced the first authorisation of Filsuvez®, marking a pivotal event in the…
Europe
Swissmedic Announces New Role for Laboratory IT Systems Specialist in OMCL
Swissmedic, Switzerland’s surveillance authority for medicines and medical devices, has disclosed an exciting new opportunity in its Laboratory Department, particularly…
Europe
Swissmedic Authorises New Therapeutic Use for Trecondi®
Swissmedic has announced an update regarding the medication Trecondi®. On October 31, 2025, the regulatory body extended the drug’s therapeutic…
Europe
Swissmedic Grants First Authorisation for SWAN-PSMA-1007®: Key Regulatory Insights
On October 31, 2025, Swissmedic announced the first authorisation of SWAN-PSMA-1007®, marking a significant regulatory milestone. This development is relevant…
Europe
Swissmedic Updates Position Paper on Decentralised Clinical Trials: Key Changes Explained
On October 31, 2025, Swissmedic and swissethics announced an update to their position paper on decentralised clinical trials (DCTs) for…
Europe
Swissmedic Approves Extended Therapeutic Indication for Omvoh®
Swissmedic has announced an important update regarding the therapeutic scope of Omvoh®. The newly approved indication offers enhanced application potential…
Europe
Safety Alert: Recall of NaCl B. Braun Infusion Solution Batch
Swissmedic has issued an announcement regarding the immediate recall of batch number 251347651 of NaCl B. Braun infusion solution. This…
Latest News
FDA Accelerates Biosimilar Approvals to Cut Treatment Costs for Chronic Diseases
The U.S. Food and Drug Administration (FDA) has announced measures to streamline the development of biosimilar drugs. These steps aim…
Latest News
Zingerman’s Recall: Allergy Hazard Due to Undeclared Peanuts & Cashews
Zingerman’s Candy Manufactory, based in Ann Arbor, Michigan, has issued an urgent recall concerning two of its candy bar products,…
Latest News
FDA Notice: E.A. Sween Issues Recall for Deli Express BBQ Pulled Pork Sandwich Due to Choking Risk
E.A. Sween Company has initiated a recall of its Deli Express® BBQ Pulled Pork sandwiches after discovering the potential presence…
Latest News
FDA Alert: Purity Products Recalls ‘MyBladder’ Supplement Over Potential E. coli Contamination
On October 27, 2025, Purity Products, based in Plainview, NY, issued a voluntary recall of one lot of its dietary…
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