Drugs

Drug Safety-related Labeling Changes (SrLC) Database

The Drug Safety-related Labeling Changes (SrLC) database provides information on approved safety-related labeling changes, initiated by companies or required by FDA, from January 2016 forward. Older SrLC data are available through the MedWatch Medical Product Safety Information Archive.

The SrLC database, allows the public to download and search SrLC data. The database functionality also enables health information technology vendors to efficiently gather, organize and distribute information related to drug safety label changes.

Created and maintained by the Office of Communication (OCOMM) in the Center for Drug Evaluation and Research (CDER), updates to the database occur as close to the labeling supplement approval as possible. The SrLC database was previously named the Drug Safety Labeling Changes (SLC) database. The name change to Drug Safety-related Labeling Changes database reflects that the data includes more than the safety label changes required or ordered by FDA under the authority granted by the Food and Drug Administration Amendments Act (FDAAA) of 2007.

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

Contact FDA

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(855) 543-3784, or
(301) 796-3400
druginfo@fda.hhs.gov

Human Drug Information
Division of Drug Information (CDER)
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Silver Spring, MD 20993

 

 

Page Last Updated: 11/01/2018
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