Whitepapers
FDA approves gene therapy for rare form of vision loss
The U.S. Food and Drug Administration (FDA) has approved the use of Spark Therapeutics’ gene therapy Luxturna (voretigene neparvovec-rzyl) for the treatment of a rare
FDA issues new draft guidance for Orphan Drug development
The U.S. Food and Drug Administration (FDA) published its recommendation for a new approach to drug development for rare pediatric diseases. The new approach supports
The EMA has updated its practical guidance for pharmaceutical companies for procedures related to Brexit
From 30th March 2019, when the United Kingdom’s (U.K.) is expected to withdraw from the European Union (EU), all EU law will no longer apply
Amsterdam will be the new host of the EMA
Amsterdam has been selected as the new post-Brexit home for the European Medicines Agency (EMA). It was chosen in a draw of lots between it
EMA and EUnetHTA publish a 3 year collaboration plan to improve efficiency and quality
The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have finalised “a joint work plan outlining key areas of collaboration
