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 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 ...
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 ...
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 ...
Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...
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.
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 ...
FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback