US FDA's innovation pathway to halve processing time for PMAs
This article was originally published in RAJ Devices
The US Food and Drug Administration is planning to launch a priority review programme for approving breakthrough medical devices1.
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Regulatory and scientific discussions undertaken by the European Medicines Agency’s human medicines evaluation committee are finding their way into a new internal repository.
Companies can have their EU centralized marketing authorization application and submission for an Article 58 opinion (on medicines for use in non-EU countries) reviewed in parallel by the European Medicines Agency. The simultaneous assessment can be helpful when drugs and vaccines are needed for both EU and non-EU populations.