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EMA/FDA

Fighting antimicrobial resistance globally

EMA, FDA and PMDA discuss regulatory approaches for the evaluation of new antibacterial agents Alignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics…

FDA approved changes to the SUSTIVA label

FDA recently approved changes to the SUSTIVA (efavirenz) product labeling to include a new Warnings and Precautions regarding QTc prolongation. The following main changes to the product labeling were made:…

FDA approved changes to the GENVOYA label

Recently, FDA approved changes to the GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), 150/150/200/10 mg fixed-dose combination tablet product labeling. The following main updates were made: 1. Longer term safety,…

“Adaptive pathways” to drug authorisation: adapting to industry?

Evidence for benefits to patients and public health of adaptive pathways is lacking or contradictory, say Courtney Davis and colleagues. Read the full analysis here: “Adaptive pathways” to drug authorisation…

Adaptive pathways: EMA still leaves open questions unanswered

Current EMA report on the pilot project again documents perplexity regarding the use of “real world data” At the beginning of August,  the European Medicines Agency (EMA) published a report…

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…