Regulations.gov document
Ref. 32 - ICH Harmonized Tripartite Guideline: Comparability of…
Supporting & Related Material · FDA-2021-D-0404 · posted Mar 18, 2022
Key facts
| Document ID | FDA-2021-D-0404-0032 |
|---|---|
| Title | Ref. 32 - ICH Harmonized Tripartite Guideline: Comparability of Biotechnological/Biological 1455 Products Subject to Changes in their Manufacturing Process: Q5E, November 2004, Re: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Draft Guidance for Industry |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2021-D-0404 |
| Posted | Mar 18, 2022 |
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