# Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/review-of-drug-master-files-in-advance-of-certain-anda-submissions-under-gdufa/bd04aec8-c53e-4d1d-b770-a5c8267fed47

> FDA guidance document: Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. Issue date: October 17, 2024. Get complete insights and analysis.

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## Details

- Title: Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2024-10-17
- Last Changed: 2024-10-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2022-D-2061">FDA-2022-D-2061</a>

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