The U.S. Food and Drug Administration (FDA) has approved Waskyra (etuvetidigene autotemcel), marking a significant milestone…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
FDA Moves to Include Bemotrizinol in Sunscreen Formulations: A Regulatory Update
The U.S. Food and Drug Administration (FDA) announced a major step forward in sunscreen product development…
FDA Authorizes Two New Oral Treatments for Gonorrhea, Marking a Regulatory Milestone
The U.S. Food and Drug Administration (FDA) has approved two novel oral therapies for gonorrhea, a…
Urgent Recall: Hameln Pharma Ltd Issues Safety Notice for Clarithromycin 500mg Infusion Powder
Hameln Pharma Ltd has issued a Class 2 Medicines recall for specific batches of Clarithromycin 500…
FDA Highlights Nationwide Recall of ReBoost Nasal Spray Over Microbial Risks
MediNatura New Mexico, Inc. has issued a voluntary recall of one lot of ReBoost Nasal Spray…
Swissmedic Alerts on Compromised Originality Seals for Urapidil Stragen i.v. – Critical Notice for Healthcare Providers
On December 12, 2025, Swissmedic issued an important notice regarding compromised originality seals on specific packaging…
Swissmedic Announces Appointment of Two New Members to Agency Council for 2026–2029 Term
On December 12, 2025, Swissmedic announced the addition of two new members to its Agency Council,…
Cargill Issues Voluntary Recall of Nutrena® Country Feeds® Cracked Corn Due to Elevated Aflatoxin Levels
On December 9, 2025, Cargill Animal Nutrition & Health announced a voluntary recall of one specific…
FDA Alerts: ReBoost Nasal Spray Recalled Nationwide Due to Microbial Contamination
MediNatura New Mexico, Inc. has announced a voluntary nationwide recall of one lot of its ReBoost…
Critical Updates: Field Safety Notices Issued from 1 to 5 December 2025
Clinical, quality, and regulatory teams should take note of the latest Field Safety Notices issued during…