The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out its proposed regulatory approach to ...
An expert and officials from the US Food and Drug Administration (FDA) offered tips for de novo classification requests and ...
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), ...
Australia's Therapeutic Goods Administration (TGA) is holding a consultation into a planned temporary increase to medical device annual charges.
Congress should enact a specific regulatory framework for artificial intelligence (AI) models developed and used in academic ...
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 UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring ...
The European Medicines Agency (EMA) is holding a consultation into the methodological aspects of confirmatory platform ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
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