# ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/andas-pre-submission-facility-correspondence-related-to-prioritized-generic-drug-submissions/44de7e09-5433-4834-a1c2-11c6a384c15e

> FDA guidance document: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions. Issue date: June 16, 2025. Get complete insights and analysis.

---

## Details

- Title: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
- 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: 2025-06-16
- Last Changed: 2025-06-16
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-3101">FDA-2017-D-3101</a>

## Related Documents

- [Cover Letter Attachments for Controlled Correspondences and ANDA Submissions:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/cover-letter-attachments-for-controlled-correspondences-and-anda-submissions-guidance-for-industry/2b16776c-c5b5-4985-bb58-5746b2e77188)
- [Controlled Correspondence Related to Generic Drug Development](https://www.globalkeysolutions.net/guidances/guidance-document/controlled-correspondence-related-to-generic-drug-development/55babf6e-6cea-4e6c-80f6-3892feff9aab)
- [Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/cannabis-and-cannabis-derived-compounds-quality-considerations-for-clinical-research-guidance-for-industry-guidance-for-industry/529cc738-130c-4b4d-afb4-d2ea5f0fe894)