The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new monitoring requirements following a review…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
FDA Warns of Dislodged Deaeration Chambers in Vantive Prismaflex Dialysis Tubing Sets
The FDA has issued an early alert regarding a critical issue with certain Vantive Prismaflex dialysis…
Swissmedic Approves Redundancy Plan for Headcount Reduction
Swissmedic has finalized a redundancy scheme in response to an announced staff reduction at the organization.…
Swissmedic Expands Approval for Calquence® Therapeutic Indication
On January 15, 2026, Swissmedic officially approved an extension of the therapeutic indication for Calquence®, marking…
Temporary Authorization for Abilify i.m. Injection Solution Due to Supply Shortage
Swissmedic, Switzerland’s authority for therapeutic products, has announced the temporary authorization for the distribution of Abilify…
Swissmedic Confirms New Blood Donation Guidelines to Address vCJD Concerns
On February 1, 2026, new blood donation criteria from Swiss Transfusion SRC will take effect, marking…
Spring & Mulberry Recalls Mint Leaf Date Sweetened Chocolate Bars Over Salmonella Concerns
Spring & Mulberry Issues Recall of Mint Leaf Chocolate Bars Over Potential Salmonella Contamination On January…
FDA Draft Guidance Advances Use of Bayesian Methods in Clinical Trials
The U.S. Food and Drug Administration (FDA) has issued new draft guidance aimed at streamlining clinical…
FDA Authorizes First Pediatric Treatment for Rare Menkes Disease
The U.S. Food and Drug Administration (FDA) has approved Zycubo (copper histidinate) injection, marking a significant…
Swissmedic welcomes Vincenza Trivigno as new Executive Director
On January 12, 2026, Swissmedic, the Swiss agency responsible for the authorization and monitoring of therapeutic…