USA – FDA issues guidance on drug development for neovascular age-related AMD
The US Food and Drug Administration (FDA) has issued draft guidance for industry on the development of drugs to treat neovascular or “wet” age-related...
UK – NICE recommends wider use of statins to cut risk of heart attack...
Up until now, NICE has recommended that those with a 10% or higher risk over ten years of a cardiovascular event should be offered...
USA – FDA finalizes PK-based dosing guidance for PD-1/PD-L1 inhibitors
The US Food and Drug Administration (FDA) this week finalized guidance detailing how sponsors of programmed cell death receptor-1 (PD-1) and programmed cell death-ligand...
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Stakeholders want the US Food and Drug Administration (FDA) to narrow its scope of what it considers labeling in a draft guidance for prescription...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...
USA – FDA finalizes umbrella trial guidance for cell and gene therapies
The US Food and Drug Administration (FDA) laid out its recommendations for sponsors to study multiple versions of a cellular or gene therapy in...
Europe – EMA confirms measures to minimise risk of serious side effects with Janus...
EMA’s human medicines committee (CHMP) has endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of serious side effects with...
