FDAnews Drug Daily Bulletin

FDA Offers Updated Online FARs Filing Following Successful Pilot Program

June 26, 2017

Drugmakers now have the option of filing the FDA’s Field Alert Report (FAR) form online, following a successful four-year pilot program.

Under federal regulations, sponsors of new and abbreviated new drug applications are required to submit FARs, known as Form FDA 3331a, to the FDA within three days of being alerted to a potential safety issue, such as bacterial contamination or packaging problems.

Use of the automated form over the course of the pilot program has improved the speed and efficiency of reporting on product quality issues, according to the agency, as well as provided feedback that was incorporated into the new, electronic version of the form. — Gayle S. Putrich

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