An expert and officials from the US Food and Drug Administration (FDA) offered tips for de novo classification requests and ...
The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out its proposed regulatory approach to ...
Commissioner Kyle Diamantas touted the agency’s new rare disease framework as the best mechanism for modernizing rare disease ...
Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), ...
Congress should enact a specific regulatory framework for artificial intelligence (AI) models developed and used in academic ...
Study: Patient, consumer reps at FDA adcomms increasingly hold ties to pharma-backed advocacy groups
At some advisory committee meetings, more than half of patient and consumer representatives who attended had connections to ...
Australia's Therapeutic Goods Administration (TGA) is holding a consultation into a planned temporary increase to medical device annual charges.
The US Food and Drug Administration (FDA) sent warning letters to two major healthcare product manufacturers—Baxter ...
The US Food and Drug Administration (FDA) on Tuesday finalized guidance to address how sponsors can develop, distribute, and ...
A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to ...
The European Medicines Agency (EMA) is holding a consultation into the methodological aspects of confirmatory platform ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, ...
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