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Thursday, February 07, 2013 7:24:34 PM
To: ALS Community Advocates
From: Advocacy - MDA
Date: January 30, 2013
Please ensure that our voice is heard — submit your request to the FDA by Feb. 8, 2013!
We are pleased to share news of a landmark opportunity for our ALS community. On February 25, 2013, the U.S. Food and Drug Administration (FDA) will hold a public hearing that will be open to individuals and caregivers affected by ALS, ALS clinical research experts, and those with a strong and passionate voice about the needs of our community.
We urge our entire ALS community to participate, either in person or in writing. Please do all you can to help ensure that the unified voice of our ALS community is heard.
Hearing remarks and written submissions may pertain to topics of importance to you and your ALS experience and/or expertise, including:
•the tremendous unmet medical needs within our community;
•considerations pertaining to benefit/risk decisions when participating in clinical trials and undergoing therapies;
•accelerated drug approval and compassionate use programs within the FDA;
•disease burden in daily life with ALS; and much more.
Click here to read the comment that was recently submitted to the FDA regarding these issues by MDA and ALSA.
Click here to read the official FDA hearing notice, and learn more about submitting comments or attending the meeting. Please note that all requests to participate, either in person or in writing, must be submitted to the FDA by February 8,
This is a rare opportunity to impact therapeutic development and ALS health policy — please join us!
mda.org/advocacy
Annie Kennedy
MDA Senior Vice President - Advocacy
http://mda.org/advocacy/news/FDA-Convenes-ALS-Public-Hearing-February-25
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