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Drug Safety Labeling Changes (SLC) Database

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 in downloadable and searchable formats.

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, the FDA expects that prompt access to these vital safety data by health care providers and consumers will better promote patient health.

The Drug Safety Labeling Changes (SLC) database provides approved safety labeling changes from January 2016 forward. Data prior to January 2016 will continue to be available on the MedWatch website.

Search the Drug Safety Labeling (SLC) database
Search approved safety labeling changes by drug name, active ingredient, date range or labeling section.

It’s here! FDA’s Drug Safety Labeling Changes (SLC) Database

Drug Safety Labeling Changes: Now Searchable!  Now Downloadable! Timely Updates!

 Searching the SLC database is simple!

 See Quick Reference

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