Agenda - Workshop on the use of Bayesian statistics in clinical development

ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials

New guideline on inclusion of pregnant and breastfeeding individuals in clinical trials

Patients and consumers

Referral: Mysimba, naltrexone,bupropion Article 20 procedures European Commission final decision, 27/03/2025, 22/05/2025, 03/06/2025

Questions and answers on the refusal of the marketing authorisation for Atropine sulfate FGK (atropine sulfate)

Clinical Trials Information System (CTIS): Information day, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 22 May 2025, 12:30 (CEST) to 22 May 2025, 17:30 (CEST)

Human medicines European public assessment report (EPAR): Cholestagel, colesevelam, Date of authorisation: 09/03/2004, Revision: 26, Status: Authorised

European Medicines Agency decision CW/0001/2025 of 2 June 2025 on class waivers in accordance with Regulation EC No 1901-2006 of the European Parliament and of the Council

Class waivers