Annual Reportable Labeling Changes for New Drug Applications …
https://www.federalregister.gov/documents/2024/03/13/2024-05293/annual-reportable-labeling-changes-for-new-drug-applications-and-abbreviated-new-drug-applications
Web ResultMar 13, 2024 · Changes to an approved NDA or ANDA, including labeling changes, are categorized into one of three reporting categories: major, moderate, or minor. [ 4 ] “Minor changes” include certain changes that have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product …
DA: 21 PA: 30 MOZ Rank: 85