• FDA Calls for Proposed Industry Labeling Standards

    The US Food and Drug Administration is proposing to study how to best standardize medical device labeling by polling healthcare providers and is calling on industry to generate recommended labeling formats and contents. FDA opened a comment period on the proposed study back in November 2011, and received comments from industry group AdvaMed questioning the utility of the study, the accuracy of the estimated burden, the validity of the methodology and the subject to be ...
  • FDA Releases Order to Protect Antimicrobial Drug From Use in Food Animals

    The US Food and Drug Administration today released an order, titled, " New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition ", that is aimed at prohibiting the off-label use of cephalosporin antimicrobial drugs in certain food-producing animals. The agency found that off-label use of the antimicrobial in food-producing animals was likely to be unsafe and represent a risk to the public. The rule follows an attempt to regulate the antimi...