USA – FDA issues final guidance user fees for combination products
The US Food and Drug Administration (FDA) on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the...
France – Publication et entrée en vigueur de l’annexe 1 des bonnes pratiques de...
Les bonnes pratiques de fabrication (BPF) des médicaments regroupent l’ensemble des recommandations qui assurent que les produits sont fabriqués et contrôlés de manière conforme...
Switzerland – Déclarations d’effets indésirables présumés de vaccins contre le COVID-19 évaluées en Suisse
Depuis le rapport standard final sur les déclarations d’effets indésirables présumés des vaccins COVID-19 évaluées en Suisse de fin février 2023, 720 déclarations ont été évaluées....
International – WHO publishes guidance for HPV vaccine developers to help tackle cervical cancer
Currently the main cause of cervical cancer – the fourth most common cancer in women globally – HPV is a very common group of...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024
PRAC elects new chair
The July 2024 meeting of EMA’s safety committee (PRAC) was the last plenary meeting chaired by Sabine Straus, who retires as Chair after...
USA – FDA releases draft guidance on use-related risk analysis for combo products
The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting.
The committee recommended granting a marketing authorisation for Balversa (erdafitinib), for the treatment of adult...
USA – FDA drafts guidance on essential outputs for drug delivery devices
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing “essential drug delivery...
Europe – EMA proposes revamping COVID-19 vaccine guidance for the post-pandemic era
The European Medicines Agency (EMA) is proposing to update its COVID-19 guidances to reflect new developments in the non-clinical and clinical development areas. It...
USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological...
This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of...
