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Drugmakers get return-to-normal guidance from FDA

A new temporary guidance for drug and biologics manufacturers from the US Food and Drug Administration (FDA) details recommendations for returning to normal production operations during the public health emergency of the COVID-19 pandemic...[FDA]

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A Quality Agreement Primer: Reviewing Regulations & Enforcement Activity

With many companies utilizing contract manufacturing and contract laboratories, quality agreements...

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MHRA Will Work Together with Agencies from Australia, Canada, Singapore and Switzerland

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has joined the Australia-Canada-Singapore-Switzerland...

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Le autorità regolatorie dell'UE richiedono di testare le quantità di nitrosammine per i farmaci a base di metformina

'EMA e le autorità nazionali competenti dell'UE contatteranno tutti i titolari di autorizzazione...

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