FDA TO POST APPLICATION AMENDMENTS AS THEY ARE RECEIVED

The FDA will now immediately post new drug, abbreviated new drug and biologics license application amendments online to improve electronic access to drug information, the agency says.

The FDA will make companies' "changes being effected" (CBE) submissions available electronically once they are received, the agency announced in a Sept. 20 Federal Register notice. Previously, the agency had waited until the supplement was approved before posting it. Companies submit CBEs to make postapproval labeling changes.

This change is meant to "make the most current labeling submitted to FDA available to healthcare practitioners and the public and to facilitate the DailyMed initiative," the agency said. DailyMed is a computerized repository of drug information.

If, after reviewing the CBE, the agency decides it should not be approved, the FDA will remove the data from DailyMed and amend the information on that site. A company should not submit the CBE supplement to the agency until it is ready to distribute this information publicly, the agency added.