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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.
Sage Products, a manufacturer of medical cosmetics, devices and OTC drugs, has seen positive results from a new software system designed to more accurately track its work-in-progress inventory and in-transit materials throughout the supply chain, a company official said.
The FDA Nov. 2 began requiring drug manufacturers to submit certain prescription human drug label information in the structured product labeling (SPL) format to make the data in agency-approved package inserts more accessible to healthcare providers and consumers.
The FDA Nov. 2 began requiring drug manufacturers to submit certain prescription human drug label information in the structured product labeling (SPL) format to make the data in agency-approved package inserts more accessible to healthcare providers and consumers.
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.
The XML-based structured product labeling (SPL) format for human drug labeling content will provide benefits beyond compliance with FDA electronic submission mandates, an industry expert said.
The FDA has updated its August 2003 draft guidance on submitting regulatory filings in the electronic common technical document (eCTD) format to include more specific instructions about the organization of eCTD submissions.
The XML-based structured product labeling (SPL) format for human drug labeling content will provide benefits beyond compliance with FDA electronic submission mandates, an industry expert said.
Switching to the structured product labeling (SPL) format for labeling content submissions will require pharmaceutical manufacturers to make some adjustments in their IT infrastructures, experts said.
The FDA has developed "validation and conformance rules" to help drugmakers properly submit structured product labeling (SPL) documents to its new electronic labeling information processing system (ELIPS).