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...
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...
USA – FDA issues draft guidances covering BIMO inspections
The US Food and Drug Administration (FDA) has issued two draft guidances on bioresearch monitoring (BIMO) inspections. The first covers information to assist the...
