RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • PhRMA: FDA Labeling Guidance May Run Afoul of First Amendment, Discounts Value of 'Trade Dress'

    The pharmaceutical industry group Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on the US Food and Drug Administration (FDA) to make several changes to a recent guidance for industry document intended to reduce medication errors by standardizing the way information is displayed on labels and cartons-not just the labeling itself. Background The guidance document, Safety Considerations for Container Labels and Carton Labeling Design to Minimiz...
  • FDA Issues New Drug Labeling Recommendations Intended to Avoid Medication Errors

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry recommending changes to the way companies place safety information on container labels and cartons, saying the changes are intended to reduce the number of medication errors. Background A 2006 report by the US' Institute of Medicine (IOM), a government think tank of sorts focused on healthcare, found that a major source of medication errors could be attributed to product labeling. ...