Flamingo Pharma UK Ltd has issued a Class 4 Medicines Defect Notification for Amitriptyline Hydrochloride tablets.…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
Swissmedic Announcement: Expanded Indication for Sarclisa®
Swissmedic has issued an important update for healthcare and regulatory professionals regarding Sarclisa®. An extension of…
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…
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…
Swissmedic Launches 2025 Oversight Fee Self-Declaration: Key Details for Medical Device Professionals
Swissmedic, Switzerland’s authority for therapeutic products, has announced the self-declaration deadline for the 2025 oversight fee.…
Swissmedic Expands Therapeutic Indication for Jemperli®
On December 5, 2025, Swissmedic announced an extension to the therapeutic indication for Jemperli®, emphasizing its…
Swissmedic Announces New Extension of Indication for Tevimbra®
On December 5, 2025, Swissmedic published an update regarding the therapeutic indication of Tevimbra®. This regulatory…
Swissmedic Expands Tevimbra® Indication: Key Regulatory Update
Swissmedic, the Swiss Agency for Therapeutic Products, has officially announced the approval of an extended therapeutic…
FDA Grants Conditional Approval for Cattle Treatment Addressing New World Screwworm and Fever Ticks
The U.S. Food and Drug Administration (FDA) has granted conditional approval for Exzolt Cattle-CA1 (fluralaner), a…