Swissmedic Issues Recall for GlucoSaline B. Braun Infusion Solution Batch
Swissmedic has announced a recall of batch number 242867651 for the product GlucoSaline B. Braun Infusion Solution. This action affects…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Europe
Europe
Swissmedic Updates: Safety Revisions to Product Information Starting November 2025
Swissmedic has announced a significant update regarding the publication of safety-related revisions to product information. Effective November 2025, clinicians, regulatory…
Europe
Swissmedic Announces Initial Authorisation of ZYNYZ® – Key Updates for Industry Professionals
Swissmedic has granted the first authorisation for ZYNYZ®, marking a significant regulatory milestone. This development signals an important step for…
Europe
Swissmedic Grants First Authorization for DATROWAY®: A Regulatory Milestone
On November 14, 2025, Swissmedic officially announced the first authorization of DATROWAY®, marking an important step in regulatory approvals for…
Europe
Swissmedic Grants First Authorization for Pylclari®: Key Updates for Regulatory Teams
On November 14, 2025, Swissmedic officially announced the first regulatory authorization of Pylclari®, marking an important step in medical device…
Europe
Swissmedic Announces Enhanced Use of Enhertu® for Extended Therapeutic Indications
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has announced the authorization of an extended therapeutic indication for Enhertu®. This update…
Latest News
FDA Announces Appointment of Richard Pazdur as New CDER Director
The U.S. Food and Drug Administration (FDA) has confirmed that Dr. Richard Pazdur, a seasoned expert with 26 years of…
Europe
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 and 80mg film-coated tablets.…
Europe
Swissmedic Opens Dynamic Role in Information & Documentation Services
Swissmedic has announced a compelling opportunity for professionals within clinical, quality, and regulatory sectors. The agency is recruiting for the…
Europe
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) in Switzerland during 2024.…
Latest News
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 supporting women’s health by…
Europe
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 following stability testing concerns.…
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