JD Supra

FDA Releases Final Quality Management System Regulation Amendments

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 ...
JD Supra

FDA Aligns U.S. Medical Device Quality System Regulation with International Standards

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...
BioWorld

FDA: proper ‘attitude’ now a requirement under device regs

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 ...
The National Law Review

FDA Final Rule Harmonizes Medical Device Quality System Regulation with International Standard

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
PharmTech

EMA and FDA Collaborate on Framework for AI Use in Drug Development

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