Where Does The Field Of Regenerative Medicine Stand?
As of mid-year 2018, there were more than 950 regenerative medicine therapies in clinical trials, of which more than 90 are in Phase III.
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Accelerated approval would help agency monitor gene therapies for durability and off-target effects, US FDA commissioner says.
CBER Director Peter Marks says center will mobilize necessary resources to make sure these provisions are implemented; Marks also offered comments in opposition to 'right-to-try' legislation.
Potentially curative regenerative medicine therapies are no longer theoretical, but instead have become reality. As more and more gene, cell and tissue-based therapies reach the market, the need for payment solutions is becoming more pressing. The Alliance for Regenerative Medicine has consulted with payers and other stakeholders to consider the barriers to alternative payment models and look at possible solutions.