Novo Nordisk Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs) to FDA as required by 21 CFR 314.80(b).

Passage 2

You failed to develop written procedures that ensured all ADEs that are the subject of 15-day Alert reports were promptly investigated in accordance with 21 CFR 314.80(c)(1)(ii). PADE regulations require that the applicant must promptly investigate all ADEs that are the subject of postmarketing 15-day Alert reports (21 CFR 314.80(c)(1)(ii)).