Regulations.gov document
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products…
Notice · FDA-2023-D-2436 · posted Aug 24, 2023
Key facts
| Document ID | FDA-2023-D-2436-0006 |
|---|---|
| Title | Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry; Extension of the Comment Period |
| Document type | Notice |
| Subtype | Extension of Comment Period |
| Agency | FDA |
| Docket | FDA-2023-D-2436 |
| Posted | Aug 24, 2023 |
| Federal Register citation | 88 FR 57959 |
| FR document number | 2023-18235 |
| Comment period opens | Aug 24, 2023 |
| Comments due | Jul 15, 2023 |
| Effective date | Aug 24, 2023 |
At a glance
- 1–9 Pages
- No Open for comment
- 10–99 Public comments on this docket
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