FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and ...
The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
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FDA and EMA release collaborative AI framework for drug development
The joint guidance was created to ensure drug developers employ best practices when using AI.
The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, ...
The FDA’s multiyear effort to rewrite the Quality System Regulation (QSR) to align with ISO 13485 could significantly ease the regulatory burden for device makers in multiple markets, but that effort ...
BioPharma Consulting Group today announced the launch of a new digital transformation advisory framework designed to ...
The Food and Drug Administration proposed a risk-based framework to enhance oversight of pharmacy compounding practices, according to an AHA News Now report. FDA Commissioner Margaret Hamburg, MD, ...
While the FDA says it has eased or thwarted “hundreds of new drug shortages” in the U.S. over the past 10 years, quality problems, global supply chain weaknesses, unexpected demand spikes, market ...
In the unforgiving landscape of medical device development, where regulatory deadlines intersect with clinical imperatives ...
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