# Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/refuse-to-file-nda-and-bla-submissions-to-cder-guidance-for-industry/9d29f151-eed6-4c49-afde-4bcd7fa65bf7

> FDA guidance document: Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry. Issue date: December 13, 2017. Get complete insights and analysis.

---

## Details

- Title: Refuse to File: NDA and BLA Submissions to CDER 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: 2017-12-13
- Comment Close Date: 2018-03-12
- Last Changed: 2020-04-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-6554">FDA-2017-D-6554</a>

## Related Documents

- [Establishing Impurity Specifications for Antibiotics](https://www.globalkeysolutions.net/guidances/guidance-document/establishing-impurity-specifications-for-antibiotics/5bb8badb-7c32-4b76-bfc9-bbb8ab55fb84)
- [Labeling for Combined Hormonal Contraceptives Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/labeling-for-combined-hormonal-contraceptives-guidance-for-industry/551e37b0-1741-4094-9133-77fbce2ceb68)
- [Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/gastroparesis-clinical-evaluation-of-drugs-for-treatment-guidance-for-industry/4b7bc445-8e11-4ce8-a6d6-3439f06daab5)