UK – Responding to new final draft guidance from NICE for a new gene...
Professor Sir Stephen Powis, NHS National Medical Director, said: “This transformative gene therapy is the first of its kind for haemophilia B patients on...
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...
Europe – Health Technology Assessment : Guidance on reporting requirements for multiplicity issues and...
This guidance describes how to deal in practice with multiplicity issues and
complementary analyses (like specific subgroup analyses, specific post hoc analyses and sensitivity analyses)...
Europe – Health Technology Assessment : Guidance on outcomes for joint clinical assessments
Clinical outcome assessments (COAs), used in clinical studies (whether they are interventional (also called experimental), or observational), are a key component of health technology...
Europe – Faster access to clinical trial information in Europe
The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024
Review of painkiller metamizole started
Review will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections,...
Europe – Two new advice pilots to improve clinical trials in Europe
The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching two advice pilots aimed at improving the quality of applications for clinical trials, the...
Europe – Annual report 2023
The Management Board’s oversight role covers the full range of EMA programmes and activities, making sure that the Agency works effectively and co-operates successfully...
Europe – Procedural advice on paediatric applications
The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007. Its objective is to improve the health of children...
UK – New restrictions on puberty blockers
The government has today introduced regulations to restrict the prescribing and supply of puberty-suppressing hormones, known as ‘puberty blockers’, to children and young people under 18 in...
