Swissmedic has issued an announcement regarding the immediate recall of batch number 251347651 of NaCl B.…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
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…
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…
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…
FDA Grants Emergency Use Authorization for Screwworm Treatment in Dogs
The U.S. Food and Drug Administration (FDA) has taken an important regulatory step to address New…
Health Canada Shares Stakeholder Feedback on Co-Packaged Drug Products Guidance
Health Canada has released insights on stakeholder feedback regarding its draft guidance for co-packaged drug products,…
Swissmedic Expands Therapeutic Indication for Palforzia®
Swissmedic, Switzerland’s agency for the authorization and supervision of therapeutic products, has announced an extension of…
Swissmedic Announces Authorization of Ayvakyt®: A Clinical Update
Swissmedic, the Swiss agency for therapeutic products, has announced the first regulatory authorization for Ayvakyt®. This…
Swissmedic Grants Initial Authorization for Wainzua®: Key Regulatory Update
Swissmedic, the Swiss agency responsible for licensing and monitoring therapeutic products, has announced the initial authorization…