FDA Makes Drug Safety Labeling Change Information Easier to Access

Posted 01 September 2016 | By Zachary Brennan 

FDA Makes Drug Safety Labeling Change Information Easier to Access

The US Food and Drug Administration (FDA) on Thursday announced the safety labeling changes (SLC) program will be managed by its Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM), which has created a new database that provides data to the public in downloadable and searchable formats.

“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,” CDER director Janet Woodcock said in an email to staff.

And while the prior MedWatch program posted safety labeling changes on a monthly basis, 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,” she added.

The new CDER database will include SLC data from January 2016 forward, and prior data will continue to be available on the MedWatch Web site.

The enhancements are also expected to allow health information technology vendors to more efficiently gather, organize and distribute information related to drug safety label changes, FDA said.

Drug Safety Labeling Changes (SLC)

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles