The U.S. Food and Drug Administration (FDA) has confirmed that Dr. Richard Pazdur, a seasoned expert…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Urgent Medicines Recall: Atorvastatin 20mg & 80mg Tablets from Sun Pharma Due to Stability Concerns
Sun Pharma UK Limited has issued a precautionary recall of specific batches of their Atorvastatin 20mg…
Swissmedic Opens Dynamic Role in Information & Documentation Services
Swissmedic has announced a compelling opportunity for professionals within clinical, quality, and regulatory sectors. The agency…
Swissmedic Reports Adverse Events from Immunization in 2024: Key Insights
On November 5, 2025, Swissmedic released a comprehensive annual report detailing adverse events following immunization (AEFI)…
HHS Updates Hormone Therapy Guidelines: Removing Misleading FDA Warnings for Women’s Health
The U.S. Department of Health and Human Services (HHS) has taken a pivotal step forward in…
Medicine Recall: Zambon SpA Issues Precautionary Withdrawal of Emylif 50mg Film Over Stability Concerns
Zambon SpA has issued a recall of its Emylif 50mg orodispersible film as a precautionary measure…
Regulatory Update: Swissmedic Confirms Morphinum Capsule Integrity Issues
On November 10, 2025, Swissmedic issued an important notification regarding Sevre-Long® (morphinum), a prescription medication commonly…
Swissmedic Issues Recall for Amoxicillin OrPha 1g Due to Quality Concerns
Swissmedic has announced a recall of batch B323BE of Amoxicillin OrPha 1g powder for injection or…
Fresenius Kabi Recalls Famotidine Injection Due to Elevated Endotoxin Levels in Reserve Samples
On November 6, 2025, Fresenius Kabi announced a voluntary nationwide recall of three lots of Famotidine…
First Swissmedic Authorisation for KIMMTRAK®: A Key Milestone in Oncology Therapy
Swissmedic has released a pivotal regulatory announcement regarding the authorisation of KIMMTRAK®, marking its first approval…