TITLE

Pathway for Approval of a Gene Therapy Orphan Product: Treading New Ground

AUTHOR(S)
Byrne, Barry J
PUB. DATE
August 2013
SOURCE
Molecular Therapy;Aug2013, Vol. 21 Issue 8, p1465
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The author reflects on the approval of a gene therapy orphan product by the U.S. Food and Drug Administration (FDA). He discusses the Food and Drug Administration Safety and Innovation Act (FDASIA) as well as the development of innovative medicines. He also tackles impact of the passage of the legislation on patients with rare and orphan diseases.
ACCESSION #
89470999

 

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