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New USP chapter details lifecycle approach to analytical testing

The United States Pharmacopoeia (USP) has released a new chapter 1220 ahead of publication in the USP-NF that sets a lifecycle approach to analytical method development with the goal of easing the process for instituting post-approval changes for analytical methods. The chapter will become official on 1 May 2022.
 
The USP chapter complements efforts underway at International Council for Harmonisation to develop a Q14 guideline to make it easier for manufacturers to switch analytical methods for testing medicines...[RAPS-USP]

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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