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Orphan Unknowns: What the MHRA Guidance Will Mean After Brexit

Blog series: Maintaining Regulatory Momentum in the Covid-19 era: Developers of orphan drug products face some important changes with the approval process in the UK after Brexit. To help companies prepare, the MHRA published new guidance: “How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB)”. While most of […]

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Applying for Orphan Drug Designation: Should the USA always be your first regulatory target?

In this article we examine 5 common myths surrounding FDA vs. EMA applications for Orphan Drug Designation applications. Download PDF: Microsoft Word – ODD – Should the USA always be first regulatory target