Field Alert Report Submissions: FDA Offers Draft Q&A
The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing the agency’s current thinking on the requirements for submitting field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs).Specifically, an NDA or ANDA applicant must submit a FAR to FDA within three working days of receiving the following kinds of information for distributed drug product(s):
“(i) Information concerning any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article.
(ii) Information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specification established for it in the application.”
As part of its push to move away from manual data entry to a more automated system of receiving FARs, FDA conducted a pilot project that concluded in June, and a new version of the automated form—Form FDA 3331a, NDA/ANDA Field Alert—which incorporates feedback from pilot project participants, was approved by the Office of Management and Budget (OMB).
The form is available on FDA’s Field Alert Reports website, and though CBER did not participate in the pilot program, applicants holding NDAs or ANDAs regulated by CBER may also use the new form.
Questions, and sub-questions, and answers in the draft include:
- “What is a FAR and what triggers its submission?”
- “Who is responsible for submitting the FAR?”
- “When should I submit a FAR?”
- “How do I submit a FAR?”
- “Where do I submit a FAR?”
- “Should I submit a follow-up or final FAR?”