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27

Gen

A look at FDA's data on priority and competitive generics

Three years into the second Generic Drug User Fee Amendments (GDUFA II) program, the US Food and Drug Administration (FDA) has seen the number of priority and competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) approved or under review rise as generic drugmakers continue to pursue both designations....[FDA-RAPS]

26

Feb

EMA updates IDMP Implementation Guide, plans further revisions

EMA has updated its identification of medicinal products (IDMP) implementation guide, providing...

26

Feb

AIFA: tep 1 della call for review sulla nitrosammine: valutazione del rischio

Il comitato per i medicinali per uso umano (CHMP) ha richiesto che tutti i titolari dell'autorizzazione...

25

Feb

Indian drugmakers look to reduce dependence on China-made APIs

Since June 2020, India and China have seen their relations sour due to skirmishes at the border. And...

24

Feb

New Zealand seeks feedback on adopting new PIC/S Guide to GMPs

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is holding a public consultation...

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