# Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/interacting-with-the-fda-on-complex-innovative-trial-designs-for-drugs-and-biological-products-guidance-for-industry/915195b1-fcb7-4359-b741-f4ca3ed67b13

> FDA guidance document: Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products:  Guidance for Industry. Issue date: December 16, 2020. Get complete insights and analysis.

---

## Details

- Title: Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2020-12-16
- Last Changed: 2024-04-09
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-3679">FDA-2019-D-3679</a>

## Related Documents

- [Long Term Follow-up After Administration of Human Gene Therapy Products:   Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/long-term-follow-up-after-administration-of-human-gene-therapy-products-guidance-for-industry/5f3e0db9-8c8a-45b5-864f-6250a3250b1b)
- [Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/recommendations-for-screening-testing-and-management-of-blood-donors-and-blood-and-blood-components-based-on-screening-tests-for-syphilis-guidance-for-industry/55e82ed9-047c-4235-9442-7dc1d1a9a4d0)
- [Human Gene Therapy for Hemophilia:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/human-gene-therapy-for-hemophilia-guidance-for-industry/bceafce9-c9f0-4137-9ca5-071464212a06)
