Zdrowie i gospodarka · 30/12/2011

FDA Restricts Ovarian Adnexal Mass Assessment Score Test Systems with Black Box Warning

The FDA is updating the regulation for ovarian adnexal mass assessment score test systems to require a black box warning in all labeling, advertising, and promotional materials, addressing a risk identified in the special controls guidance document, to mitigate the risk to health associated with off-label use.