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EMA/FDA

European Commission publishes three-year report on implementation of pharmacovigilance legislation

Closer collaboration between the European Medicines Agency (EMA), the European Commission and the EU Member States, enabled by the new European pharmacovigilance legislation, has enhanced the monitoring of the safety…

Transparency in drug regulation

Publication of assessment reports in Europe and Australia makes information on medicines more easily available In a joint article published by Drug Discovery Today, the European Medicines Agency (EMA) and…

EMA: Adaptive pathways – key learnings and next steps

EMA publishes report on pilot project and will organise workshop in December to further explore concept The European Medicines Agency (EMA) has published a final report on the experience gained…

EMA overcomes its own prejudice to approve PrEP in Europe: four years too late

On 22 July 2016, the European Medicines Agency (EMA) overcame their own organisational blocks and finally recommended granting authorisation in for TDF/FTC to be used as PrEP in the European…

EMA: Development of medicines to treat TB

Comments on draft guidance invited until 31 January 2017 The European Medicines Agency (EMA) has launched a public consultation on revised guidance on the development of new medicines to treat…

FDA approves once-daily VIEKIRA XR

AbbVie receives U.S. FDA approval of once-daily VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of genotype 1 chronic hepatitis C - New extended-release formulation is the first…

CHMP grants positive opinion for shorter treatment duration with VIEKIRAX in genotype 4

CHMP grants positive opinion for shorter treatment duration with AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) for patients with genotype 4 chronic hepatitis C with compensated cirrhosis (Child-Pugh A) - The CHMP opinion…

CHMP recommends generic tenofovir

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended for approval generic tenofovir, Tenofovir disoproxil Zentiva (tenofovir disoproxil), for the treatment of HIV-1 infection and chronic hepatitis…

First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU

Truvada to enhance existing HIV prevention strategies The European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union (EU) for Truvada (emtricitabine / tenofovir disoproxil) for…

EMA: Proposals to revise guidance on first-in-human clinical trials

Comments invited on a concept paper on changes intended to support best practices The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the…