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Blog Post

European Medicines Agency’s new guide on the wording of therapeutic indication

On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in...

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 ...

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