Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry September 2024

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA September 10, 2024 https://www.fda.gov/drugs/news-events-human-drugs/anda-submissions-amendments-abbreviated-new-drug-applications-under-gdufa-09102024