Regulations.gov document
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products…
Notice · FDA-2023-D-2436 · posted Jul 14, 2023
Key facts
| Document ID | FDA-2023-D-2436-0001 |
|---|---|
| Title | Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2023-D-2436 |
| Posted | Jul 14, 2023 |
| Federal Register citation | 88 FR 45222 |
| FR document number | 2023-14917 |
| Comment period opens | Jul 14, 2023 |
| Effective date | Jul 14, 2023 |
At a glance
- 1–9 Pages
- 10–99 Public comments on this docket
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Regulations.gov documents
Regulations.gov holds the rulemaking and other documents federal agencies post for public comment. Only agency documents are published here; public submissions are not.
Source: Regulations.gov (U.S. General Services Administration eRulemaking Program) · Source date: