The Food and Drug Administration is updating its guidance for drugmakers and makers of biological products submitting safety reports electronically for the first time in six years. Comments are being accepted until Aug. 11.
The FDA has issued a final rule requiring that post-marketing safety reports be submitted in an electronic format. The rule goes into effect June 10, 2015.
Safety reports are included in the FDA Adverse Event Reporting System, which often can produce key pieces of evidence in products-liability litigation.
Individual case safety reports of adverse drug experiences should include the manufacturer’s name, the name of the suspect medical product, relevant hospital discharge summaries, autopsy reports, death certificates and published articles based on scientific literature.
The guidance does not apply to vaccines, components of whole blood or human cells and tissues.
The submissions should go to the FDA’s Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.
If the FDA’s electronic portals are unavailable, drugmakers are advised to check back within 24 hours to see if the FDA is having problems and to submit on physical media only if the electronic portals are down for more than 48 hours.
Amaris Elliott-Engel contributes to law.com.