Urgent Action Item - FDA Draft Guidance for ALS

[rknt50a]

The FDA has issued its draft guidance and we are in the comments period.

The guidance is not acceptable in the opinion of many of us. It "strongly recommends that sponsors conduct randomized, placebo-coltrolled, double-blind studies..." "Historically controlled trials for ALS are strongly discouraged..."

We'll certainly not have any new trial designs with guidance like that.

A vet with ALS has supplied links to the document along with information about leaving comments during the official period for comments. After that, we're stuck with what we get from the FDA.

https://shellyhoover.wordpress.com/2018/02/19/get-on-board-or-get-out-of-my-way/

Thanks if you will read and act. The FDA seems to have been tone deaf to what people with ALS and caregivers and those on the guidance document committees have been telling them.

 

[rknt50a]

Excellent material from Hope Now for ALS to help people compose comments.
https://www.facebook.com/hopenowforals/posts/2095322057355798

Please comment to the FDA if you have not done so already. If this guidance is made final by the FDA, it will stifle all innovation in clinical trial design.

Thanks, all. ALSA is mysteriously agnostic on this one, and it's up to individuals to speak up!

 

[rknt50a]

The comments period ends April 16. If this draft guidance from the FDA is made final, that will institutionalize the status quo for clinical trial design in the US. We must not let that happen.

Below are some sites with information for your consideration. ALS organizations are silent on their positions so far, so it's up to us. Please submit your comments.

Thanks.

https://www.facebook.com/hopenowforals/posts/2095322057355798

ALS Advocacy: Guest Blogger: It's Crunch Time. Take Your Shot!

ALS Advocacy: Dear FDA,