FDA: Drug safety labeling changes program now available in new, user-friendly format

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FDA: Drug safety labeling changes program now available in new, user-friendly format

FDA announced that the safety labeling changes (SLC) program will be managed by the Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM). OCOMM has established a new “Drug Safety Labeling Changes (SLC)” database that provides these data to the public in downloadable and searchable formats.

According to Janet Woodcock, CDER director, “With this transition, safety labeling change (SLC) data on the Web will now be available much faster for health care providers, health information technology vendors, and the public to view, search, and download." She added, the SLCs will be now be housed in a CDER database and published “as close to the day of the labeling supplement approval as possible."

New SLC database provides approved safety labeling changes from January 2016 forward Data prior to July 2016 will continue to be available on the FDA MedWatch Web site. FDA said that these enhancements will allow health information technology vendors to more efficiently gather, organize and distribute information related to drug safety label changes. Providing drug safety labeling changes to health care vendors as quickly and efficiently as possible facilitates having the data further integrated into systems frequently accessed by health care providers. Ultimately, FDA expects that prompt access to these vital safety data by health care providers and consumers will better promote patient health.

FDA

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