Day: February 1, 2024

In a change more than 20 years in the making, the FDA released the final rule for good manufacturing practices (GMP) for medical devices this week. Although most of the changes incorporated into the final quality systems (QS) regulations have been practically implemented through various policies over the last decade, the final rule contains a … Read more

It has been required since 1998 that race and ethnicity information be presented with clinical trial results included in market approval applications for all FDA-regulated products. However, there exists signification confusion about the specific demographic sub-groups that should be collected and the standardized approach that should be followed leading to variability in the reported data. … Read more