FDA requires drug makers to submit digital labeling info.The FDA is requiring drug makers to submit labeling information digitally, a move it says will increase access and pave the way for use of other electronic healthcare tools.
The requirement, led by FDA's Center for Drug Evaluation and Research (CDER), is part of a larger effort to update drug labels.
The agency is expected to release new layout and content standards that could completely change the appearance of labels. "We are expecting to issue, at some point in the future, the physician labeling rule, which would require that all labels be formatted in a consistent, more easy-to-read
and understand format," CDER spokeswoman Crystal Rice told MM&M. Making the switch to the digital format means companies must submit labels that use embedded computer tags to enable the data to be searched. Over the next year, they will have to submit digital versions of currently marketed products. All label data will be grouped in one place, a public online archive kept by the National Library of Medicine located at http://dailymed.nlm.nih.gov, rather than on each drug maker's Web site. Eventually the FDA will provide the information at its own site, one that will include information on all FDAregulated products.