6:30 AM
Jul 11, 2018
 |  BC Extra  |  Politics & Policy

FDA releases gene therapy guidance documents

Editor's Note: This article was updated on Jul 11, 2018 at 7:47 AM PDT

FDA Wednesday released six draft guidance documents on gene therapy: three advising companies on how to use the technology to treat certain diseases, two about manufacturing and one on the design of long-term follow-up studies.

The disease-specific draft guidance documents provide advice about developing gene therapies for hemophilia, retinal disorders and rare diseases.

Rare diseases are attractive...

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