FDA's oversight of clinical trials is becoming an increasingly significant factor in regulatory delays for some products, and a recent warning letter could have a very broad impact: it cites a clinical investigator for six trials related to three separate NDAs
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If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
