The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Draft Guidance on Oxymetazoline Hydrochloride." The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for oxymetazoline hydrochloride ophthalmic solution.
| Document Number | 2024-06985 |
| FR Citation | 89 FR 23021 |
| Type | Notice |
| Published | Apr 3, 2024 |
| Effective Date | - |
| RIN | - |
| Docket ID | Docket No. FDA-2007-D-0369 |
| Pages | 23021–23023 (3 pages) |
| Text Fetched | No |
| Part | Name | Agency |
|---|---|---|
| No linked CFR parts | ||
| Type | Proposed | Final | Method | Conf |
|---|---|---|---|---|
| No paired documents | ||||
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