November 02, 2005
FDA Requires Electronic Drug Labels
Drug makers will be required to submit any new or updated labels in a digital format under a new drug label protocol FDA officials announced today. Currently, there is no central source with up-to-date label information, although most drug makers post labels on their Web sites and the information is included on the FDA Web site.
The new protocol, which is the first stage of the FDA's larger effort to update drug labels, will require drug makers to submit digital versions of all existing labels to the agency within the next year. The National Library of Medicine will compile the digital labels into an online public archive, called Daily Med, and the FDA will also be launching a Web site containing the drug label information, as well as information about medical devices and other products the agency regulates.
This electronic format is supposed to make it easier for consumers and health-care providers to access drug product information that's already found in the FDA-approved package inserts for all approved medications in the United States.
The government expects to have labels for most of the available prescription drugs posted on the Web site of the National Library of Medicine -- http://dailymed.nlm.nih.gov -- within a year.
Posted by rsk at November 2, 2005 11:59 PM