The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance for industry entitled "Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics" that appeared in the Federal Register of December 6, 2024. In the notice of availability for the draft guidance, FDA requested comments on the draft guidance. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
| Document Number | 2025-01179 |
| FR Citation | 90 FR 5899 |
| Type | Notice |
| Published | Jan 17, 2025 |
| Effective Date | - |
| RIN | - |
| Docket ID | Docket No. FDA-2024-D-2033 |
| Pages | 5899–5900 (2 pages) |
| Text Fetched | No |
| Part | Name | Agency |
|---|---|---|
| No linked CFR parts | ||
| Type | Proposed | Final | Method | Conf |
|---|---|---|---|---|
| No paired documents | ||||
| Doc # | Type | Title | Published |
|---|---|---|---|
| 2026-02386 | Notice | Agency Information Collection Activities... | Feb 6, 2026 |
| 2024-28392 | Notice | Expedited Program for Serious Conditions... | Dec 6, 2024 |
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