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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 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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