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 mg powder for concentrate…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Europe
Latest News
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 across the United States…
Europe
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 units of Urapidil Stragen…
Europe
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, marking a crucial step…
Latest News
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 lot of Nutrena® Country…
Latest News
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 Nasal Spray as of…
Europe
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 the first week of…
Europe
Safety Notice: Flamingo Pharma UK Updates Required in Amitriptyline Hydrochloride PILs
Flamingo Pharma UK Ltd has issued a Class 4 Medicines Defect Notification for Amitriptyline Hydrochloride tablets. The Patient Information Leaflets…
Latest News
Critical FDA Alert: Power Management Issues in GE HealthCare Anesthesia Systems
The U.S. Food and Drug Administration (FDA) has issued an early alert regarding a potentially high-risk issue in certain anesthesia…
Europe
Swissmedic Announcement: Expanded Indication for Sarclisa®
Swissmedic has issued an important update for healthcare and regulatory professionals regarding Sarclisa®. An extension of the therapeutic indication has…
Latest News
FDA Unveils TEMPO Pilot Program to Boost Safe Access to Digital Health Tools for Chronic Diseases
The U.S. Food and Drug Administration (FDA) has announced a groundbreaking initiative aimed at improving access to digital health technologies.…
Latest News
FDA Introduces TEMPO Digital Health Pilot to Improve Chronic Disease Care Access
The U.S. Food and Drug Administration (FDA) unveiled the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot on…
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