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Pharmaceutical manufacturers face a new FDA mandate to incorporate the “Problem List” subset of the Systematized Nomenclature of Medicine (SNOMED) into their electronic labeling as of June 30, although many are more familiar with the international Medical Dictionary for Regulatory Activities (MedDRA).
Radio frequency identification (RFID) product tags have long been touted as a panacea for the problem of counterfeit and gray market drugs, but other technologies — both familiar and new — can also offer protection, according to specialists at a recent industry convention.
While the current electronic common technical document (eCTD) holds "a ton of value" for FDA-regulated life science companies, leveraging the Health Level Seven (HL7) standards can vastly improve eCTD benefits, said Ken VanLuvanee, president and CEO of Apyx.
Medical device manufacturers, physicians' offices and others involved in the edata chain of patient information are struggling to adopt electronic health records (EHRs) because of cost barriers and a lack of standards, experts told PIR last week.
The FDA should take the lead in establishing industry electronic submission standards but is not likely to do so with any speed unless pushed by companies, vendors and others in the industry, according to the FDA’s acting chief information officer.