US regulators are stepping up efforts to reduce animal use in early drug development. On 18 March 2026, the US Food and Drug Administration issued draft guidance encouraging companies to swap or reduce animal studies where credible human-relevant tools exist. This marks an important recognition of the growing range of animal testing alternatives available to researchers. The FDA says a…
Tag: Regulatory Affairs
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FDA Biosimilar Development Guidance Targets Treatment Costs
\n\nBiologic medicines are made from living cells and are among the most expensive therapies available. While they account for only 5% of all prescriptions, they are responsible for a staggering 51% of total drug spending in the United States. To address this imbalance, the FDA is prioritising the expansion of the biosimilar market.\n\n\n\nThe new FDA biosimilar development guidance focuses on…