FDA Speeds Up Drug Safety Labeling Changes Notifications

FDA says it has speeded up its release of drug safety information on its Web site that houses labeling changes made post approval. “Our improved Drug Safety Labeling Changes Program enables FDA to post the latest safety information about a medicine almost at the same time we approve a change, as opposed to once a month,” says CDER Division of Drug Information director Mary E. Kremzner in an online post. She says that within days of approval, new drug safety information is entered into the safety labeling changes database. Health information technology vendors that provide clinical and drug information support for hospitals and pharmacies are then alerted to integrate the safety labeling changes data into their systems. “So instead of waiting weeks for the monthly release of all safety labeling updates, this information is now accessible in days,” she says. Additionally, a searchable database provides a comprehensive listing of the labeling changes related to safety for that product over its lifetime.