With End of Pilot Project, FDA Introduces Updated Form To Submit FARs Electronically
FDA’s voluntary pilot project that introduced industry to an automated form for field alert report (FAR) submissions has been successful. The following objectives of the pilot project, which launched in May 2013, have been met:
(1) allow simultaneous reporting to FDA’s Office of Regulatory Affairs (ORA) district offices and FDA’s Center for Drug Evaluation and Research (CDER), and
(2) determine the feasibility of transitioning from a simple PDF to a functional PDF with automated processing using extensible markup language (XML).
Use of the automated form has improved the speed and efficiency of reporting on product quality issues related to the manufacture of drug products approved under a new drug application (NDA) or abbreviated new drug application (ANDA) by FDA.
FDA’s website has more information about the updates to Form 3331a and about field action reports.