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Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicants

Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval after submission compared to batch manufacturing products, according to results from a US Food and Drug Administration (FDA) audit published in the International Journal of Pharmaceuticals.

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FDA: Hope for user fee reauthorization

While the US Food and Drug Administration has warned that it would need to lay off staff in the first...

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Farmaci biosimilari in Italia: report AIFA aggiornati a maggio 2022

L’Agenzia pubblica i report sul monitoraggio dei farmaci biosimilari in Italia, aggiornati ad maggio 2022. Oltre...

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Impact Factors for Sourcing

How is current market volatility, led by inflationary pressures, supply-chain disruptions, and geopolitical...

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AIFA - Synchron Research Service: il riesame conferma la sospensione di medicinali a causa di irregolarità negli studi

Il Comitato per i medicinali per uso umano (CHMP) dell'EMA ha confermato la propria raccomandazione...

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