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In order to curb an ever-growing number of medical errors involving the administration and prescription of drugs, the federal government and industry must overhaul the way medications are named, labeled and packaged, a recent federal study concluded.
Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) have released a revised draft labeling order for medicines under the joint Australia New Zealand Therapeutic Products Authority.
Encoding unique device identification (UDI) on devices would likely benefit all device stakeholders except manufacturers, concludes a recent report conducted by Eastern Research Group (ERG) for the FDA.
Encoding unique device identification (UDI) on devices would likely benefit all device stakeholders, except manufacturers, concludes a recent report conducted by Eastern Research Group (ERG) for the FDA.
Problematic online advertising of a skin graft product is the subject of an official letter the FDA sent to LifeCell, Branchburg, N.J., and Wright Medical Technology, Arlington, Tenn.
IVAX Pharmaceuticals has issued a national recall for its Goldline brand 500 mg Extra Strength Genapap (acetaminophen) and Extra Strength Genabs (acetaminophen) tablets and caplets due to a labeling error.
IVAX Pharmaceuticals has issued a national recall for its Goldline brand 500 mg Extra Strength Genapap (acetaminophen) and Extra Strength Genabs (acetaminophen) tablets and caplets due to a labeling error.
The FDA’s Center for Drug Evaluation and Research (CDER) has released a draft technical document on how to use structured product labeling (SPL) Release 2, which incorporates changes in the requirements for the content and format of labeling for human prescription drug and biological products.
The FDA will require manufacturers of newly approved prescription drug products, as well as products approved within the last five years, to use the “Problem List” Subset of the Systematized Nomenclature of Medicine (SNOMED) in electronic labeling by June 30.
Health care providers are concerned that questions about how the FDA defines a hospital for the purpose of its rule requiring bar codes on drug labels could affect their ability to comply with the rule, a hospital official says