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ICH Q12: FDA guidance explains US implementation

ICH Guidance for Industry Q12 - Implementation Considerations for FDA-Regulated Products       [Final edition 19 May 2021]

The US Food and Drug Administration (FDA) has issued draft guidance to help manufacturers implement the International Council for Harmonization’s (ICH) Q12 guideline on postapproval changes by explaining how manufacturers can submit established conditions (ECs) for new drug applications (NDAs) and prior approval supplements (PASs). It also reconciles ICH post-approval changes classification categories with FDA supplement categories....[FDA]

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Covid-19, Governo approva decreto legge su misure urgenti per fronteggiare l’emergenza e per l’esercizio in sicurezza di attività sociali ed economiche

Proroga fino al 31 dicembre 2021 dello stato di emergenza nazionale, modifica dei parametri che definiscono...

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India reports steep rise in API prices

India, which is just about emerging out of a deadly second wave of Covid-19, is now battling with...

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FDA’s domestic inspections return to normal; overseas inspections still affected

For the first time since March 2020, the FDA’s inspections of US-based biopharma sites have 

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