Accelerated approval and accelerated withdrawal – will the new clinical trial guidance bring US closer to Europe?
Written by: Srishti Gupta, PhD; Senior Consultant Contact: [email protected] In March 2023, the Food and Drug Administration (FDA) published, a first of its kind, draft
Orphan Drug market, how is Italy doing? The latest OSSFOR Booklet paints a favourable picture for the Italian landscape.
By Marco Sancandi, PhD; Analyst On the 31st of January 2023, the 6th joint report from the Orphan Drugs Observatory and the Italian Society of
By Fisentzos Stylianou, PhD; Senior Analyst The UK will be the first country to introduce a regulatory framework for innovative medicines manufactured at the point
Official countdown for the implementation of the Joint European Health Technology Assessment (EUnetHTA) begins!
Written by Priyanka Kiritharan, Analyst Contact: [email protected] Taking effect from January 2025, all advanced therapeutic medicines (ATMPs) and oncology drugs will be mandated to undergo
By Fisentzos Stylianou, PhD; Senior Analyst Contact: [email protected] “I can say on behalf of the G-BA that it is possible that we will recognise some
By Fisentzos Stylianou, PhD Contact: [email protected] NICE’s launches a real-world evidence framework Closing knowledge gaps and advancing patient access to innovations are major aims of the
By Priyanka Kiritharan, Analyst Email: [email protected] Last month, France’s HTA body; Haute Autorite De Sante (HAS) changed its criteria that triggers the cost-effectiveness evaluation of products
By Fisentzos Stylianou, PhD Contact: [email protected] One of the main healthcare challenges raised by the European Medicines Agency’s (EMA) network strategy to 2025 is the