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Re: Mikesc post# 132245

Wednesday, 11/29/2017 11:08:56 AM

Wednesday, November 29, 2017 11:08:56 AM

Post# of 461201
Anyone know what these 11 RMA designations are/include?

One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies.

The Cures Act recognized these opportunities and highlighted the need to establish enhanced pathways for these promising therapies. Immediately after the law passed, CBER moved quickly to establish the Regenerative Medicine Advanced Therapy (RMAT) designation program, as authorized in section 3033. This program aims to facilitate an efficient development program, expedited review of innovative regenerative medicine therapies, and provide more timely access to potentially life-saving products. Products granted designation are eligible for increased early interactions with FDA, including all the benefits available to breakthrough therapies. As of October 31, FDA had granted 11 RMAT designations.



http://docs.house.gov/meetings/IF/IF14/20171130/106667/HHRG-115-IF14-Wstate-GottliebS-20171130.pdf

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