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Blog Post

New drug marketing applications: how do EMA and FDA compare?

A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period ...

Blog Post

European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries ...

Blog Post

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products.[1] The purpose of this guideline is to provide applicants and...

Blog Post

EMA publishes draft guideline on the quality of water for pharmaceutical use

The EMA has published a draft Guideline on the quality of water for pharmaceutical use. The draft is intended to provide guidance to the industry. It concerns the pharmaceutical use of...

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EMA launches public consultation on the use of patient disease registries for regulator purposes

On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of...

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