Regulations.gov document
Determining Whether To Submit an Abbreviated New Drug Application or 505(b)(2)…
Notice · FDA-2017-D-5974 · posted Jan 12, 2018
Key facts
| Document ID | FDA-2017-D-5974-0008 |
|---|---|
| Title | Determining Whether To Submit an Abbreviated New Drug Application or 505(b)(2) Application; Draft Guidance for Industry; Availability; Reopening of the Comment Period |
| Document type | Notice |
| Subtype | Request for Comments |
| Agency | FDA |
| Docket | FDA-2017-D-5974 |
| Posted | Jan 12, 2018 |
| Federal Register citation | 83 FR 1618 |
| FR document number | 2018-00405 |
| Comment period opens | Jan 12, 2018 |
| Comments due | Feb 13, 2018 |
| Effective date | Jan 12, 2018 |
At a glance
- 1–9 Pages
- No Open for comment
- 1–9 Public comments on this docket
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