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news

News from the world

24

Sep

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 half of September if Congress did not reauthorize its user fee programs, the agency has not yet done, so indicating its optimism that a bill will be passed before carryover funds run out. This week, several news outlets reported that Senate Republicans and Democrats have struck a deal to include a clean reauthorization bill in a stopgap spending bill that will allow the user fee programs to continue after their 30 September expiration...[FDA - RAPS]

23

Sep

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...

23

Sep

Impact Factors for Sourcing

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

22

Sep

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...

22

Sep

FDA braces for user fee reauthorization delay even as DMF submissions rise in H1 2022

Though the year 2021 was eclipsed by the Covid-19 pandemic, there was no let up in the speed at which...

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