# Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/formal-meetings-between-fda-and-anda-applicants-of-complex-products-under-gdufa-guidance-for-industry/86088692-efb1-40f5-89a1-4490b41c5955

> FDA guidance document: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry. Issue date: October 05, 2022. Get complete insights and analysis.

---

## Details

- Title: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA 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: 2022-10-05
- Last Changed: 2023-01-11
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-5739">FDA-2017-D-5739</a>

## Related Documents

- [Competitive Generic Therapies](https://www.globalkeysolutions.net/guidances/guidance-document/competitive-generic-therapies/402bfb2a-4126-427d-9a19-4507e22c6b0e)
- [Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/post-complete-response-letter-clarification-teleconferences-between-fda-and-anda-applicants-under-gdufa-guidance-for-industry/04568e14-0429-4c8d-ac7e-f865e2dc2669)
- [Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/product-specific-guidance-meetings-between-fda-and-anda-applicants-under-gdufa-guidance-for-industry/46fd1a27-e84d-47dd-b1fe-94fef41f16db)