Regulations.gov document
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal…
Notice · FDA-2013-D-0811 · posted Mar 1, 2016
Key facts
| Document ID | FDA-2013-D-0811-0022 |
|---|---|
| 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of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2013-D-0811 |
| Posted | Mar 1, 2016 |
| Federal Register citation | 81 FR 10632 |
| FR document number | 2016-04372 |
| Comment period opens | Mar 1, 2016 |
| Comments due | Jun 1, 2016 |
| Effective date | Mar 1, 2016 |
At a glance
- 1–9 Pages
- No Open for comment
- 100–999 Public comments on this docket
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