US FDA to device makers: it’s good to talk
This article was originally published in Clinica
The US Food and Drug Administration has issued updated guidance that describes the types of communications the agency is using to engage with medical device companies when reviewing marketing applications.
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Three companies are set to learn this week whether the European Medicines Agency will fast track its review of their soon-to-be-filed EU marketing applications.
Janssen and AstraZeneca are among a raft of companies that might this week find out whether the European Medicines Agency will recommend approval of their products for expanded therapeutic indications.
Oral explanation meetings are due to take place this week for drug sponsors who have a final chance to address questions and concerns the European Medicines Agency has about their marketing applications.