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US FDA - Identifying Trading Partners Under the Drug Supply Chain Security Act

The Food and Drug Administration (FDA or Agency) is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). This guidance revises the Agency’s draft guidance for industry Identifying Trading Partners Under the Drug Supply Chain Security Act (August 2017) to address the status of some entities as trading partners (e.g., private-label distributors, salvagers, and returns processors and reverse logistics providers), provide clarification on certain drug distribution scenarios...[FDA]

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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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