Regulations.gov document
Reference 4 Supplemental Guidance on Testing for Replication Competent Retrovirus in…
Supporting & Related Material · FDA-1999-D-0081 · posted Jan 30, 2020
Key facts
| Document ID | FDA-1999-D-0081-0057 |
|---|---|
| Title | Reference 4 Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During re Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-1999-D-0081 |
| Posted | Jan 30, 2020 |
At a glance
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