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news

News from the world

10

Sep

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]

30

Nov

ICH recaps progress made over past year, charts new topics

The International Council for Harmonisation (ICH) announced that “significant milestones”...

25

Nov

UE: Parlamento, proposte per farmaci più accessibili e convenienti

I deputati europei hanno avanzato proposte per rendere i farmaci più accessibili e convenienti,...

25

Nov

L'industria dei generici europea sollecita interventi per sostenere la produzione di principi attivi e medicinali nel Vecchio Continente

The EU must stop the offshoring of essential medicines manufacturing investments: ambitious, open...

24

Nov

FDA floats a new approach to nitrosamine mitigation

FDA suggests alternative approaches for nitrosamine risk assessments.



The US Food...

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