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REACh: Tonnage band changes may now be taken into account during dossier evaluation process

Companies that downgrade the tonnage band in their registrations after ECHA has communicated the draft decision to them will need to prove the volume of their substance. ...[ECHA]

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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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