USA – FDA unveils rare disease innovation hub, plans public meeting this fall
The US Food and Drug Administration (US) announced the creation of a Rare Disease Innovation Hub to speed development of new treatments, integrate regulation...
USA – FDA guidance addresses developing treatments for pediatric IBD
The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to spur the development of new treatments for pediatric ulcerative colitis...
USA – FDA makes exception for antibody drug conjugates in mass balance studies final...
The US Food and Drug Administration (FDA) has finalized a guidance that lays out clinical pharmacology information that sponsors of investigational drugs conducting human...
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USA – FDA releases draft guidance on use-related risk analysis for combo products
The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...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...
