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News dal mondo

30

Nov

ICH recaps progress made over past year, charts new topics

The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline on general considerations for clinical studies and the release of question-and-answer guidelines related to the electronic Common Technical Document (eCTD)...[ICH]

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...

23

Nov

FDA says it far exceeded its projections for inspections in FY2021

In an update to its Resiliency Roadmap for FDA Inspectional Oversight, the US Food and...

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