Regulations.gov document
PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions…
Other · FDA-2018-D-1635 · posted Aug 4, 2023
Key facts
| Document ID | FDA-2018-D-1635-0005 |
|---|---|
| Title | PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR; Guidance for Industry; Draft Guidance |
| Document type | Other |
| Subtype | Guidance |
| Agency | FDA |
| Docket | FDA-2018-D-1635 |
| Posted | Aug 4, 2023 |
| Comment period opens | Aug 4, 2023 |
| Comments due | Oct 3, 2023 |
At a glance
- No Open for comment
- 1–9 Public comments on this docket
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