Saudi FDA Consults On Compassionate Use Program Requirements
The Saudi drug authority has clarified the roles and responsibilities of the various players involved with giving patients access to drugs under development on compassionate grounds.
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The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.
The European Medicines Agency has been on a steep learning curve with its qualification of a digitally-measured outcome for use in Duchenne muscular dystrophy trials, smoothing the way for other developers entering the digital biomarker space.