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FDA . Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers

US FDA's updated Q&A guidance on developing generics for submission via the abbreviated new drug application pathway during the COVID-19 pandemic has been published...[FDA]

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Publication of a new general chapter on balances in European Pharmacopoeia Supplement 10.6

At its 168th session (November 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted...

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China’s NMPA applies for pre-accession to PIC/S

On 24 September 2021, China’s National Medical Products Administration (NMPA) submitted an application...

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US FDA - Drug Registration Renewal Period Now Open

The annual drug registration renewal period is now open through December 31, 2021. To keep...

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