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PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in their October 2025 meeting. These recommendations are directly actionable by marketing authorisation holders (MAHs) for updates to product information.

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in November 2025. Marketing Authorisation Holders (MAHs) are required to provide supplementary information or update product information based on these recommendations, with specific deadlines for certain signals.

PRAC Recommendations on Signals - January 2026 Meeting

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in January 2026. Marketing Authorisation Holders (MAHs) for affected medicinal products are required to update product information within specified timelines.

PRAC Recommendations on Safety Signals

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in February 2026. These recommendations require marketing authorisation holders (MAHs) to provide supplementary information or take regulatory action, such as updating product information.

FDA Extends Drug Use Dates Due to Shortages

The FDA has extended the use dates for specific lots of certain drugs to help alleviate drug shortages. This guidance allows providers and patients to use these lots beyond their labeled expiration dates, based on manufacturer stability data. The agency is not requiring relabeling but expects replacement and disposal when new product becomes available.

Texas Pharmacy and Medical Boards Joint Statement on Communication

The Texas Medical Board and Texas State Board of Pharmacy issued a joint statement reminding physicians and pharmacists of the importance of clear communication and collaboration in patient care. The statement emphasizes professional judgment and shared responsibility in ensuring safe and legitimate prescription practices.

WHO Releases New Antibiotic Profiles for Drug-Resistant Infections

The World Health Organization (WHO) has released three new Target Product Profiles (TPPs) for antibacterial agents to address critical drug-resistant infections. These profiles guide the development of new antibiotics for multidrug-resistant Gram-negative infections, Gram-positive infections in vulnerable patients, and bacterial meningitis.

WHO Handbook Accelerates Hepatitis Elimination Action

The World Health Organization (WHO) has released a new implementation handbook to support countries in accelerating action towards hepatitis elimination by 2030. The handbook consolidates evidence-based recommendations and provides practical guidance for expanding prevention, testing, and treatment services.

Japan PMDA Drug Precaution Revisions for FY2025

The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has published a list of drug precaution revisions for Fiscal Year 2025, detailing updates for various nonproprietary drug names. These revisions are effective on specific dates in late 2025 and early 2026, with associated investigation summaries available.

PMDA Japan Drug Precaution Revisions

The PMDA Japan has updated drug precautions for several medications, including Andexanet alfa, Topiramate, and various VEGF/VEGFR inhibitors. These revisions reflect new safety information and investigation results, impacting the labeling and handling of these drugs.