Regulations.gov document
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Fixed-Combinations and…
Notice · FDA-2018-D-1635 · posted Aug 3, 2023
Key facts
| Document ID | FDA-2018-D-1635-0004 |
|---|---|
| Title | Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2018-D-1635 |
| Posted | Aug 3, 2023 |
| Federal Register citation | 88 FR 51322 |
| FR document number | 2023-16560 |
| Effective date | Aug 3, 2023 |
At a glance
- 1–9 Pages
- 1–9 Public comments on this docket
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