Research1st

Putting the Patient at the Center: FDA’s New Series Premiers with ME/CFS

Kim McCleary — Fri, 17 May 2013 22:25:29 +0000

It’s rare that ME/CFS as a disease category experiences a “first” that’s positive. Here’s one worth celebrating: the March 11, 2013 announcement by the Food & Drug Administration (FDA) that ME/CFS would be the first condition explored through the agency’s Patient-Focused Drug Development Initiative. In most of the regulatory framework that guides FDA decisions, information about [...]

CFS Advisory Committee Meets May 22-23

admin — Fri, 10 May 2013 00:48:11 +0000

The federal Chronic Fatigue Syndrome Advisory Committee (CFSAC) meets next on May 22-23, 2013 in Washington, D.C. This chartered advisory committee provides advice and recommendations to the Secretary of Health and Human Services (HHS) through the Assistant Secretary for Health on issues related to ME/CFS. Here is the Federal Register notice announcing the meeting: http://1.usa.gov/15g9vA5 [...]

CFIDS Association Announces Leadership Transition

Board of Directors — Wed, 24 Apr 2013 13:47:35 +0000

The CFIDS Association of America announces that longtime president and CEO, K. Kimberly McCleary, will be leaving her role as the organization’s CEO early this summer. Ms. McCleary joined the CFIDS Association as the organization’s first chief staff executive more than 22 years ago; her family will be relocating in June at which time she will [...]

You’re At the Center: Learn How the CFIDS Association is Fostering Developing of Safe and Effective Treatments for ME/CFS

admin — Mon, 15 Apr 2013 03:46:27 +0000

The fourth webinar in our spring series focuses on how the CFIDS Association is fostering the development of safe and effective therapies for ME/CFS. Please join us!Date/Time (Live Event): Wednesday, April 17, 2013 at 1 p.m. EDT Speakers: Suzanne Vernon, Ph.D. (Scientific Director) and Mark Stone (Director of Development), The CFIDS Association of AmericaRecording: http://bit.ly/apr-17-webinar Dr. [...]

Find Out How FDA Defines “Safe and Effective”: April 11 Webinar

Kim McCleary — Fri, 05 Apr 2013 14:52:23 +0000

View the third webinar in spring series: http://bit.ly/apr-11-webinar, recorded on April 11. In just about two weeks, the U.S. Food and Drug Administration (FDA) will host a two-day workshop on drug development for CFS and ME. The FDA’s review process is designed to test potential treatments for both safety and effectiveness for the condition they aim [...]

Upcoming Webinar: Finding Your Strongest Voice for Public Testimony

admin — Thu, 28 Mar 2013 01:49:46 +0000

The upcoming FDA Workshop on Drug Development is a historic opportunity for the ME/CFS* community to establish ME/CFS as a priority for drug development. Learn more about the FDA workshop here: http://bit.ly/fda-mtg-agenda To inform, educate and engage with the community so that our individual contributions have amplified impact, we are hosting a six-program spring webinar series and [...]

FDA Workshop Agenda & Details Announced

admin — Thu, 21 Mar 2013 19:56:26 +0000

The U.S. Food and Drug Administration (FDA) will host a workshop on drug development and CFS and ME on April 25-26, 2013. This FDA workshop will also serve as the first of 20 disease-specific meetings where the FDA will gather patients’ perspectives as part of a mandated “Patient-Focused Drug Development Initiative.” The CFIDS Association of [...]

Catalyzing Informed Action: Webinar Series & Patient Survey

Leigh Reynolds — Mon, 18 Mar 2013 22:04:36 +0000

Upcoming Webinar: Overview of the Drug Development Landscape

Leigh Reynolds — Mon, 18 Mar 2013 20:57:46 +0000

The upcoming FDA Workshop on Drug Development is a historic opportunity for the ME/CFS* community to establish ME/CFS as a priority for drug development. To inform, educate and engage with the community so that our individual contributions have amplified impact, we are pleased to announce a spring webinar series and a special patient-focused survey. Title: Overview of [...]

New $2 Million CFS Grant Awarded to Dr. Dikoma Shungu & Team

Kim McCleary — Thu, 07 Mar 2013 16:44:11 +0000

The following press release issued today announces a new $2 million research grant to a team led by Dr. Dikoma Shungu of Weill Cornell Medical College. The award from the National Institutes of Health was made based on pilot data Dr. Shungu’s team collected with support from two pilot study grants from the CFIDS Association of America. Click here for [...]