This article describes the regulatory frameworks and incentives associated with orphan drug designation (ODD) in the EU and the US, as well as capturing key strategic considerations needed to achieve successful orphan drug product development and registration in both regions.
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Artificial Intelligence has achieved major milestones in the US, with the FDA granting clearance to the first AI-based software for…
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Cultured meat products are novel in the market, there are no regulatory and CMC guidelines specifically dedicated to them. Therefore,…
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In the European Union (EU) the review and approval of medical devices and in vitro diagnostic medical devices often requires…
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Recently, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has provided updates to the guidance Software and AI…
