Regulations.gov document

Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent…

Notice · FDA-1999-D-0081 · posted Jan 30, 2020

Key facts

Document ID FDA-1999-D-0081-0051
Title Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry; Availability
Document type Notice
Subtype Notice of Availability
Agency FDA
Docket FDA-1999-D-0081
Posted Jan 30, 2020
Federal Register citation 85 FR 5448
FR document number 2020-01700
Comment period opens Jan 30, 2020
Effective date Jan 30, 2020

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  • 10–99 Public comments on this docket

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