Regulations.gov document
Bioavailability Studies Submitted in New Drug Applications or Investigational New Drug…
Notice · FDA-2018-D-4367 · posted Feb 26, 2019
Key facts
| Document ID | FDA-2018-D-4367-0001 |
|---|---|
| Title | Bioavailability Studies Submitted in New Drug Applications or Investigational New Drug Applications—General Considerations; Draft Guidance for Industry; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2018-D-4367 |
| Posted | Feb 26, 2019 |
| Federal Register citation | 84 FR 6148 |
| FR document number | 2019-03246 |
| Comment period opens | Feb 26, 2019 |
| Comments due | May 29, 2019 |
| Effective date | Feb 26, 2019 |
At a glance
- 1–9 Pages
- No Open for comment
- 10–99 Public comments on this docket
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