Anna Törner: ”Orphan Designation – the "petite robe noire" of drug development”

It is easy to cling to various regulatory incentives, like orphan designation, and other expedited pathways, without understanding what they truly mean or whether they are indeed right (or wrong) for the current project, Anna Törner writes in a column.

Marie Gårdmark: Big data evidence generation drives change in the EU regulatory system

Rapid developments in technology have led to the possibility for the generation and analysis of vast volumes of data. Will the availability of big data lead to fundamental changes to the regulatory system? In a column Marie Gårdmark, CEO and Senior Consultant at RegSmart Life Science, develops her views on this subject.

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"Det behövs en tydlig prislista"

Pelago Bioscience vd Michael Dabrowski kommenterar förslaget från SwedenBio om att tillgängliggöra forskningsinfrastrukturen.

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