# Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/enforcement-policy-regarding-investigational-new-drug-requirements-for-use-of-fecal-microbiota-for-transplantation-to-treat-clostridium-difficile-infection-not-responsive-to-standard-therapies-guidance-for-industry/1c1d8e06-4c1c-4dc5-8c6a-ebfa9ce68b55

> FDA guidance document: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies:  Guidance for Industry. Issue date: November 28, 2022. Get complete insights and analysis.

---

## Details

- Title: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies:  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: 2022-11-28
- Last Changed: 2022-11-29
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-0811">FDA-2013-D-0811</a>

## Related Documents

- [Human Gene Therapy for Rare Diseases:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/human-gene-therapy-for-rare-diseases-guidance-for-industry/1cebc8e2-7d3b-4c5f-a4c4-78d1fc112099)
- [Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/blood-pressure-and-pulse-donor-eligibility-requirements-compliance-policy-guidance-for-industry/615d0678-665d-430f-b65f-b6436cb2069f)
- [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)