The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation under 21 ...

The FDA issued a final rule which continues efforts to promote consistency in the regulation of devices and provides timelier introduction of safe and effective high-quality devices for patients.

The U.S. FDA’s Jan. 14 webinar for the new Quality Management System Regulation included some fairly predictable content, but one member of the FDA staff mentioned that the agency now expects ...

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The U.S. FDA dropped the final rule for the Quality Management System Regulation (QMSR), the long-awaited blending of the agency’s own Quality System Regulation (QSR) and ISO 13485.

FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and ...

Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

Purpose-built electronic quality management systems are a better fit for CGT production than traditional technologies.