FDA To Hold ALS Public Hearing: Input Encouraged by Feb. 8

by ALSN Staff on Wed, 2013-01-30 12:25

The Food and Drug Administration will hold a public hearing on amyotrophic lateral sclerosis (ALS) on Feb. 25

Article Highlights:
  • Feb. 8 is the deadline to submit requests to participate in the U.S. Food and Drug Administration’s public hearing on ALS, which will convene on Feb. 25.
  • Input from the ALS community is strongly encouraged on such topics as unmet medical needs, clinical trials, drug approval and daily life with ALS.

The Food and Drug Administration (FDA) will hold a public hearing on amyotrophic lateral sclerosis (ALS) on Feb. 25. It will be open to individuals and caregivers affected by ALS, ALS clinical research experts, and those with strong opinions about the needs of the ALS community.

The deadline for all requests to participate, either in person or in writing, must be submitted to the FDA by February 8.

“This is a landmark opportunity for our ALS community,” says Annie Kennedy, MDA senior vice president of advocacy. “We urge the participation of our entire community — either in person or in writing — to ensure that our unified voice is heard.”

Verbal remarks and written submissions to the hearing should pertain to topics of importance to people with ALS experience or expertise. These topics might include:

  • the numerous unmet medical needs within MDA's ALS community;
  • benefit/risk decisions when participating in clinical trials and undergoing therapies;
  • accelerated approval of new drugs for ALS and compassionate-use programs; and
  • the so-called “disease burden” of daily life with ALS.

“This is a rare opportunity to impact therapeutic development and ALS health policy,” Kennedy says.

Visit the MDA website to read the official FDA hearing notice, and for more details about submitting comments or attending the meeting. 

To learn more, read the comment recently submitted to the FDA by MDA and ALSA regarding these issues.

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