Posted 16 June 2017
By Michael Mezher
The US Food and Drug Administration (FDA) on Thursday released an updated version of its automated Field Alert Report (FAR) form, following the conclusion of a successful four-year pilot program.
Under federal regulations, sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) are required to submit FARs to FDA within three days of being alerted to a potential safety issue, such as a labeling mix-up or bacterial contamination.
In May 2013, FDA announced the launch of a voluntary pilot to "modernize the FAR submission and review pathway," by allowing participating drugmakers to submit FARs electronically using an XML-enabled PDF form, known as FDA Form 3331a, rather than faxing or scanning a copy to their local FDA field office, who forwarded the form to the Center for Drug Evaluation and Research for further review.
Now, four years later, FDA says the pilot has been a success.
"Use of the automated form has improved the speed and efficiency of reporting on product quality issues," FDA writes.
FDA says it has made a number of changes to the automated form, such as making most fields in the form expandable and combining or separating certain fields to improve usability, and says sponsors must now include a data universal numbering system (DUNS) or Facility Establishment Identifier (FEI) number on the form.
Eventually, FDA says it plans to receive FAR submissions through its electronic submissions gateway used for electronic common technical document (eCTD) submissions. But for now the agency says companies should continue to follow its existing instructions for submitting Form FDA 3331a.