FDA Launches Safety Reporting Portal, Extends Deadline for Submitting ICSRs

June 1, 2015

Six years after promising a web-based alternative to its electronic submissions gateway, the FDA has launched a drug safety reporting portal for companies with a small number of adverse event reports.

Using the portal, which went live last week, holders of NDAs, ANDAs and BLAs, as well as manufacturers, packers and distributors, can issue postmarket safety reports for drugs and nonvaccine biologics without having to maintain an internal database and direct connection to the agency. They simply enter the information into the web format.

Drugmakers producing large numbers of safety reports may continue to use the electronic submissions gateway, which requires an internal database modeled on the International Conference on Harmonization’s esubmissions system.

The agency has extended the compliance deadline for registering on the portal from June 10 to Sept. 8.  The FDA promised the portal a 2009 proposed rule that was finalized last summer. At the time, the FDA said electronic collection of individual case safety reports would help reviewers identify potential safety red flags more quickly and get that information to the public.

Access the safety reporting portal at http://tinyurl.com/mvs4yy7. Tuesday’s Federal Register notice is at www.fdanews.com/05-26-15-esubmissionsdelay.pdf. — Lena Freund