Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
The US Food and Drug Administration (FDA) on Tuesday issued draft guidance on submitting investigational device exemption ...
COLUMBUS, OH – The US Food and Drug Administration (FDA) saw more new recall events for class I medical devices in 2025 than it has in recent years, a trend that continues to trouble agency officials.
The US Food and Drug Administration (FDA) issued revised draft guidance on Thursday aimed at assisting sponsors of ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out its proposed regulatory approach to ...
Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), ...
Commissioner Kyle Diamantas touted the agency’s new rare disease framework as the best mechanism for modernizing rare disease ...
The US Food and Drug Administration (FDA) sent warning letters to two major healthcare product manufacturers—Baxter ...
An expert and officials from the US Food and Drug Administration (FDA) offered tips for de novo classification requests and ...
The European Medicines Agency (EMA) is holding a consultation into the methodological aspects of confirmatory platform ...
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