Derek Woodcock gives an overview of the Pharmacovigilance System Master File in our safety and pharmacovigilance themed month. The requirement for a Pharmacovigilance System Master File (PSMF) has ...
European regulators are to review Sarepta Therapeutics’ Duchenne muscular dystrophy drug, eteplirsen – a drug that has sparked controversy in the US, where it was approved by the FDA against the ...
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