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The FDA should take the lead in establishing industry standards for electronic submissions but is not likely to do so with any urgency unless pushed by companies, vendors and others in the industry, the FDA’s acting CIO Fred Farmer said Dec. 6 at a CIO Executive Forum event in Washington, D.C.
The pharmaceutical industry has identified counterfeiting and diversion prevention, along with product reconciliation and effective stock management as key business drivers for adopting electronic product code (EPC)/radio-frequency identification (RFID) technology, according to a white paper from a nonprofit standards organization.
AssurX, a provider of enterprise quality and compliance systems, has launched a new system to help device and drug manufacturers comply with multiple regulatory requirements and manage documents relating to safety issues, customer complaints and supplier quality.
The pharmaceutical industry might not meet the FDA’s goals for widespread track-and-trace technology adoption by 2007, but drugmakers, technology companies and standards organizations are making progress in developing and using such anticounterfeiting measures, an agency official told Congress.
The FDA will continue to increase its emphasis on esubmissions next year, former agency chief information officer (CIO) James Rinaldi told attendees of the FDA Information Management Summit sponsored by FDAnews in Bethesda, Md., Dec. 1.
AssurX, a provider of enterprise quality and compliance systems, has launched a new system to help device and drug manufacturers comply with multiple regulatory requirements and manage documents relating to safety issues, customer complaints and supplier quality.
The medical device industry strongly supports pending legislation in the Senate that would make critical access hospitals (CAH) in rural communities more competitive in the race for health information technology (HIT) grants.
A nonprofit standards organization has released an electronic product code (EPC) value model that gives drugmakers insight into the costs and benefits of using the technology to secure the supply chain.
Following a "broad" four-month nationwide search, the FDA has selected an internal candidate to fill the long-vacated director position in its Office of Drug Safety (ODS), the agency announced Oct. 19.
After some lengthy delays, the FDA this month will require drugmakers to adopt the structured product labeling (SPL) format for certain human drug labeling submissions, an agency official said.