This document is an official guidance from the U.S. Food and Drug Administration (FDA) issued in December 2025. It provides the agency's current recommendations and interpretations on how clinical investigators (the doctors/researchers running clinical trials) should handle safety reporting for drugs and medical devices that are still under investigation.
Adverse Childhood Experiences (ACEs) are potentially traumatic events occurring before the age of 18. These experiences range from direct personal harm to environmental instability. The term originates from a landmark study by the CDC and Kaiser Permanente (1995-1997) which established a strong, graded relationship between ACEs and negative health outcomes in adulthood.
This is a master research protocol published by the World Health Organization (WHO) in 2025. Its primary purpose is to provide a standardized, ready-to-use blueprint for countries—particularly low- and middle-income countries (LMICs)
This is the 19th volume, 11th issue of the EPVC’s monthly newsletter, published in November 2025. It serves as an official communication from the Egyptian Drug Authority (EDA) to healthcare professionals, regulators, and the public regarding drug safety, pharmacovigilance activities, and regulatory updates in Egypt.
The UK Centre of Excellence for Regulatory Science and Innovation in Pharmacogenomics (CERSI-PGx) has developed a landmark guideline on CYP2C19 genotype testing for clopidogrel, published in the British Journal of Clinical Pharmacology in 2025.
This document is a supplementary publication from the European Medicines Agency (EMA). It provides the exact legal wording that must be inserted into the official product information for medicines, based on the safety recommendations made by the Pharmacovigilance Risk Assessment Committee (PRAC) during its October 2025 meeting.
Prescriber Update is a quarterly medical safety publication issued by Medsafe, the New Zealand Medicines and Medical Devices Safety Authority. It is intended for healthcare professionals to communicate emerging safety signals, drug risks, regulatory updates, and clinical advice.
Advancing Medication Safety Through Knowledge and Vigilance
