Here are direct links to other #genetherapy Guidance document
Hemophilia - https://www.fda.gov/media/113799/download …
Rare Diseases - https://www.fda.gov/media/113807/download …
CMC - https://www.fda.gov/media/113760/download …
The FDA finalized 6 guidance documents on #GeneTherapy development about:
- #Hemophilia
- #RareDisease
- Retinal disorders
- CMC for INDs
- LT follow-up
- Retrovirus testing
Also released new draft guidance on interpreting the sameness of gene therapies.https://www.raps.org/news-and-articles/news-articles/2020/1/fda-finalizes-6-gene-therapy-guidances-unveils-a …
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Retinal Disorders - https://www.fda.gov/media/124641/download … Long term followup - https://www.fda.gov/media/113768/download … Retroviral based - https://www.fda.gov/media/113790/download …
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