Zdrowie i gospodarka · 23/03/2011

FDA Proposes Black Box Warning for Ovarian Adnexal Mass Assessment Score Test Systems

The FDA is proposing to restrict ovarian adnexal mass assessment score test systems to include a black box warning in all labeling, advertising, and promotional material, addressing a risk identified in the special controls guidance document, in an effort to mitigate the risk to health associated with off-label use.