Regulatorische Updates

A brief summary of the MHRA’s latest safety advice for medicines and medical device users.

The FDA has initiated a recall because the product lacks assurance of sterility, raising safety concerns.

Claudin18.2‑targeted CAR‑T therapy is the first CAR‑T to receive global approval for a solid tumor.

The MHRA's ninth MedSafety Week runs 4‑10 November 2024, encouraging public reporting of medication safety issues.

A brief overview of letters and notifications sent to UK healthcare professionals about medicines and medical devices in March 2024.

The FDA has put Sobi's planned gout medication on hold, delaying its challenge to Amgen's Krystexxa.

The FDA has approved ANDA084306 for MYDRIACYL, a 1% tropicamide ophthalmic solution marketed by Alcon Laboratories.

The FDA has approved Teva Pharmaceuticals’ oral capsule generic of chlordiazepoxide hydrochloride under ANDA 084768, with multiple supplemental manufacturing and labeling approvals.

GE Healthcare reports that the CARESCAPE Central Station (CSCS) v3.0.x may not resume patient monitoring for at least three minutes after a system restart.

GE Healthcare reports that its CARESCAPE Central Station v3.0.x may fail to resume patient monitoring for at least three minutes after a system restart.

A medical law amendment to replace the term "상급종합병원" with "중증종합병원" has been introduced to clarify hospital functions and ease large‑hospital concentration.

Governments met at WHO headquarters to resume hybrid discussions on a proposed pandemic agreement, focusing on pathogen sharing, One Health and financing before the 77th World Health Assembly.