FDA Announces Pilot Program to Test New Form for NDA, ANDA Field Alerts

The Food and Drug Administration is announcing a pilot program to test a new automated form to submit new drug application (NDA) and abbreviated new drug application (ANDA) field alert reports (FARs), according to a notice published May 2 in the Federal Register (78 Fed. Reg. 25,749).

All drug manufacturers with approved NDAs and ANDAs are required to submit FARs if they find any significant problems with an approved drug, according to FDA’s website. Reports must be submitted to district FDA offices within three days of a problem being identified.

FDA said the new form, Form FDA ...