The Stakes Are High So Get It Right
CHMP Oral Explanations And FDA AdComs
The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. Consultant Kate Dion highlights to In Vivo helpful tips for companies facing this daunting situation.
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New medicines under evaluation at the European Medicines Agency.
An advanced immunotherapy for recurrent glioblastoma and the first biosimilar version of Lucentis for age-related macular degeneration have also been submitted for review by the European Medicines Agency for potential pan-EU authorization.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.