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The FDA has followed a joint advisory committee’s recommendations in removing two of three approved indications for Ketek and adding a black box warning to the antibiotic’s labeling.
The FDA has followed a joint advisory committee’s recommendations in removing two of three approved indications for Ketek and adding a black box warning to the antibiotic’s labeling.
The FDA needs to change its labeling requirements for contraceptives to incorporate data about the drugs’ effectiveness and their noncontraceptive benefits, as well as to ensure that the labels are more readable and concise, an agency advisory committee recommended.
Regulations established by the FDA and the United States Pharmacopeia (USP) for labeling parenteral infusion drug products leave significant gray areas that may put patients at risk, according to experts speaking at a recent NIH conference.
OTC drugs in very small “convenience-size” packages could qualify for “optional alternative labeling” under a proposed amendment to the FDA’s 1999 final rule on standardized format and content requirements for OTC drug labeling in general.
After examining risks related to the off-label use of drug-eluting stents, an FDA advisory panel last month recommended the agency consider mandating labeling changes.
Common OTC pain relievers would have to carry prominent new warnings about the potential for stomach bleeding and liver damage under an FDA-proposed rule.
The Department of Justice (DOJ) has entered into another multi-million dollar off-label promotion settlement, which sources say reflects an enforcement priority for the federal government.