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...
USA – Drugmakers, compounders at odds over FDA’s difficult-to-compound rule
Drugmakers laud the US Food and Drug Administration’s (FDA) proposed rule on drugs that are difficult to compound by pharmacies and outsourcing facilities. Compounders,...
USA – FDA finalizes guidance on drug development for diabetic foot infections
The US Food and Drug Administration (FDA) finalized its advice to drugmakers developing treatments for diabetic foot infections without bone and joint involvement, focusing...
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...
USA – FDA finalizes guidance giving ANDA facilities time to comply with cGMP
The US Food and Drug Administration (FDA) will give generic drug manufacturers more time to bring facilities not fully compliant with its current good...
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,...
France – Vaccination maternelle contre le VRS : une nouvelle possibilité pour protéger le...
Saisie par le ministère chargé de la Santé, la Haute Autorité de santé publie aujourd’hui une recommandation concernant l’intégration du nouveau vaccin Abrysvo dans...
International – ICH announces forthcoming documents on nitrosamine impurities, RWD
The International Council for Harmonisation (ICH) announced plans to issue two new documents: an addendum to the M7 guideline on assessing carcinogenic risk that...
