# ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/anda-submissions-refuse-to-receive-standards-questions-and-answers-guidance-for-industry/9263d6de-7354-4678-ba95-003ad712d3c3

> FDA guidance document: ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry. Issue date: October 03, 2017. Get complete insights and analysis.

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## Details

- Title: ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry
- 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: 2017-10-03
- Comment Close Date: 2018-01-02
- Last Changed: 2020-04-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-5846">FDA-2017-D-5846</a>

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