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.

With the end of the pilot project on June 15, 2017 , FDA is making a new version of the automated form—Form FDA 3331a—publicly available on its website (see FDA’s Field Alert Reports Web page ). The new version of Form FDA 3331a incorporates feedback from pilot project participants. FDA encourages all of industry to use this new automated form to submit FARs for both CDER and Center for Biologics Evaluation and Research (CBER) regulated drug products approved under an NDA or ANDA.

FDA’s website has more information about the updates to Form 3331a and about field action reports.