As of September 1, 2016, 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.
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 healthcare vendors as quickly and efficiently as possible facilitates having the data further integrated into systems frequently accessed by health care providers.
Ultimately, the FDA expects that prompt access to these vital safety data by healthcare providers and consumers will better promote patient health.