News dal mondo

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FDA unveils FY 2027 user fee rates

The US Food and Drug Administration (FDA) has published its user fee rates for FY 2027 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. The rates are calculated by factoring in the agency’s resources against the number of applications it expects to receive over the next fiscal cycle based on historical trends...[US FDA - Federal Register]

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Esenzione sui dazi per taluni prodotti provenienti dagli USA

Il 25 giugno 2026 è stato pubblicato il REGOLAMENTO (UE) 2026/1455 DEL PARLAMENTO EUROPEO E DEL...

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Inside Pharma’s Push for More Resilient Supply Chains

Industry leaders from Samsung Biologics and Fujifilm Biotechnologies discuss how regional manufacturing,...

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US FDA CDER plans new guidance on AI, electronic safety report submissions, and more

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has...

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EU DG SANTE and EMA sign Working Arrangement with New Zealand Ministry of Health

DG SANTE and the European Medicines Agency (EMA) have signed a Working Arrangement with New Zealand Ministry...