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FDA Aims to Facilitate Gene Therapy Development for Hemophilia, Rare Diseases

Posted on: 13 July 2018, source: Pharmacy & Healthcare
Significant progress has been made in gene therapy research and development over the years, with promise to treat and cure some of the most complex diseases. In a statement, FDA Commissioner Scott Gottlieb, MD, announced the agency’s latest efforts to speed up the path to approval for gene therapies, specifically for certain specialty and rare diseases. To help expedite advancement in the field, the FDA has released a new policy framework for the development, review, and approval of gene therapies to address the challenges of bringing these drugs to market.