France – Risque de méningiome et progestatifs : recommandations générales pour limiter ce risque
Les progestatifs sont des médicaments utilisés dans diverses pathologies gynécologiques (endométriose, fibromes, règles particulièrement longues et/ou abondantes, troubles du cycle), dans le traitement hormonal...
USA – FDA wants feedback on testing methods for new nitrosamines
The US Food and Drug Administration (FDA) is requesting stakeholder input on approaches for identifying and testing novel nitrosamines identified in drug products and...
USA – FDA proposes long-awaited patient medication information rule
The US Food and Drug Administration (FDA) has proposed new drug labeling requirements to make it easier for patients to understand their medication while...
USA – Stakeholders concerned with FDA’s definition of labeling in PDURS guidance
Stakeholders want the US Food and Drug Administration (FDA) to narrow its scope of what it considers labeling in a draft guidance for prescription...
Europe – EU actions to tackle shortages of GLP-1 receptor agonists
EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to tackle shortages of the...
India – Indian Pharmacopoeia joins global discussion group pilot
The international Pharmacopoeial Discussion Group (PDG) has accepted the Indian commission into a one-year pilot that is intended to expand its membership beyond the...
Europe – Best practices to fight antimicrobial resistance
The International Coalition of Medicines Regulatory Authorities (ICMRA) highlights successful regulatory and non-regulatory interventions used in different countries to address the growing public health problem of...
International – ICH : Clinical Electronic Structured Harmonised Protocol (CESHARP) M11
The clinical protocol describes the processes and procedures directing the conduct and analysis of a clinical trial of medicinal product(s) in humans. To date,...
Europe – EMA Management Board: highlights of October 2022 meeting
COVID-19
At its 6 October 2022 meeting in Amsterdam, the European Medicines Agency (EMA) Management Board heard an update on the recent activities related to...
Europe – ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement providing updated public health considerations on the...
