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 World screwworm infestations among…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Latest News
Canada
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Health Canada has released insights on stakeholder feedback regarding its draft guidance for co-packaged drug products, reflecting its ongoing commitment…
Europe
Swissmedic Expands Therapeutic Indication for Palforzia®
Swissmedic, Switzerland’s agency for the authorization and supervision of therapeutic products, has announced an extension of the therapeutic indication for…
Europe
Swissmedic Announces Authorization of Ayvakyt®: A Clinical Update
Swissmedic, the Swiss agency for therapeutic products, has announced the first regulatory authorization for Ayvakyt®. This marks a significant milestone…
Europe
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 for Wainzua®. This development…
Europe
Tamsulosin and Its Association with Intraoperative Floppy Iris Syndrome: Swissmedic Insights
Swissmedic has issued an important notice about the risks of intraoperative floppy iris syndrome (IFIS) among patients undergoing cataract surgery…
Europe
Swissmedic Updates on Veterinary Drug Reactions: Key Insights from 2024 Reports
The latest vigilance report from Swissmedic highlights significant findings regarding adverse reactions to veterinary medicinal products reported in Switzerland during…
Europe
Swissmedic Advisory: Reduced Shelf Life for Lecigon (Carbidopa/Entacapone/Levodopa)
Swissmedic has issued a health professional communication regarding a change in the shelf life of Lecigon, a medication containing carbidopa,…
Latest News
FDA Releases Internal Filing Checklists to Streamline Drug Application Reviews
The U.S. Food and Drug Administration (FDA) has officially published internal filing checklists utilized by its Center for Drug Evaluation…
Europe
Duplicate GTIN and EAN Numbers Raise Concerns for Relonchem Ltd Medicines
Healthcare professionals, regulators, and distributors should take note of a critical update related to Relonchem Ltd products. The company has…
Europe
Urgent Recall: Incorrect Labelling Found in Accord Healthcare’s Ipratropium Bromide Nebuliser Solution
An urgent recall has been issued for Ipratropium Bromide 500 microgram/2ml Nebuliser Solution by Accord Healthcare Ltd due to incorrect…
Europe
Swissmedic Approves Initial Authorization for Sogroya®: Key Details for Regulatory Professionals
Swissmedic has announced the first authorization for Sogroya®, marking a significant regulatory development. The approval introduces a new option within…
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