FDA Webinar May 18th--Seeking Patient Input

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FDA Webinar May 18th--Seeking Patient Input

Postby Shayk » Sun May 13, 2012 12:55 pm

Hi all

I've recently discovered that the FDA is hosting its "Inaugural Patient Network Meeting", entitled, Patient Input into FDA Benefit-Risk Decision-Making: Opportunities and Challenges, Friday, May 18th from 9-4:30 pm in Maryland.

This initial link has basic info about the meeting. Don't be put off when you see the registration deadline was May 4th. That deadline is only if you want to attend the meeting in person.

If you want to participate in the meeting via Webinar, you can scroll to the bottom of the page and click on "Register Now" , to register for the webinar.

If you're one of those who doesn't click through, here's info from the announcement:
FDA recognizes a need for greater understanding of how patients define and perceive benefits and risks about medical products. The FDA Patient Network is hosting this one-day meeting to:

explore the drug and medical device regulatory processes;
discuss where patient input is practical and most valuable; and,
explore practical approaches to collecting meaningful patient input.

We will hold a series of presentations, exercises, and panel discussions throughout the meeting to facilitate a conversation between FDA decision-makers and the patient community about these important topics. We anticipate valuable input from meeting participants and expert panelists on:

ways to effectively include patient input in FDA benefit-risk decision-making; and,
how to prioritize diseases or conditions to approach in future benefit-risk discussions.

This is the link to info published in the Federal Register about the meeting. It includes questions on "understanding the disease" and "assessment of treatment options".

This meeting is NOT specific to MS, but if/when the FDA schedules disease specific patient input, this is your opportunity (as one example) to let them know if those are the questions you would want them to ask people with MS or are there others you'd suggest?

Ok, too much bureacratic information....personally I'm interested in letting them know that they need to require and publish absolute (not simply relative data) about the DMDs for MS. I'll put that in another post.

Let's have people with MS, advocates, etc. participate in the meeting. :smile:

Take care all

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