Regulatory Affairs

FDA Lifts REMS for Caprelsa (vandetanib), Signaling New Safety Confidence

The U.S. Food and Drug Administration (FDA) has announced the removal of Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa…

Regulatory Update: Swissmedic Confirms Safety of Paracetamol Use During Pregnancy

Swissmedic, Switzerland’s regulatory authority for therapeutic products, has reaffirmed its position on the use of medicines containing paracetamol during pregnancy.…

Critical Updates: Field Safety Notices Issued from 8–12 September 2025

Important updates for clinical, quality, and regulatory teams: A series of Field Safety Notices (FSNs) were published between 8 and…

FDA Clears Innovative Essilor Stellest Eyeglass Lenses to Manage Pediatric Myopia Progression

The U.S. Food and Drug Administration (FDA) announced on September 29, 2025, the authorization of Essilor Stellest eyeglass lenses. This…

Olympus Recalls Specific ViziShot 2 FLEX Needles Due to Safety Concerns

Olympus Corporation has announced a voluntary global recall of certain lots of its ViziShot 2 FLEX (19G) EBUS-TBNA needles. The…

FDA Approves First Pediatric Eyeglass Lenses to Mitigate Myopia Progression

The U.S. Food and Drug Administration (FDA) has authorized the marketing of Essilor Stellest eyeglass lenses. This marks the first…

Swissmedic Grants Initial Authorisation for VANFLYTA®: Impact on Clinical and Regulatory Practices

Swissmedic has officially authorised VANFLYTA®, marking its initial regulatory approval. This announcement, dated September 30, 2025, highlights a significant development…

Critical Updates: Field Safety Notices Issued for Medical Devices (15–19 September 2025)

Healthcare professionals and regulatory teams, please take note. Between 15 and 19 September 2025, a range of Field Safety Notices…

GHWP Announces Voluntary Withdrawal from IMDRF Membership

On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew as a member of the International Medical Device…