FDA stresses support for gene therapies in issuing guidelines

29 January 2020

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The US Food and Drug Administration (FDA) has underlined its support for the field of gene therapies as it announces the release of guidelines for drug developers and manufacturers.

There are six final guidances on gene therapy manufacturing and clinical development, along with a draft guidance, entitled Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.

'A therapeutic reality'

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