FDA releases six final guidances today on #genetherapy manufacturing and clinical development of products and a draft guidance, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.
https://www.fda.gov/news-events/press-announcements/fda-continues-strong-support-innovation-development-gene-therapy-products?utm_campaign=012820_Statement_FDA%20Continues%20Strong%20Support%20of%20Innovation%20in%20Gene%20Therapy&utm_medium=email&utm_source=Eloqua …
#raredisease #viralvectors #CDMO
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