Gabby (Nielk) and Russell (Firestormm) continue our summary of the FDA Workshop with a look at the first part of Day Two – a discussion entitled “Innovation, Expedited Pathways, and Regulatory Considerations” The FDA Drug Development Workshop for Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME) took place on the 25th and 26th of April 2013. It was well attended
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Experts Reflect on the FDA Stakeholder Meeting
Joel asks a variety of leading doctors, researchers and patient advocates for their reflections on the FDA Drug Development Workshop. A short while ago, the US Food and Drug Administration (FDA) held a workshop for patients, doctors, and other stakeholders, to talk about drug development for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). You can read a summary of the first and
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FDA Drug Development Workshop: Part Two
Gabby (Nielk) continues our summary of the FDA Workshop with a look at the second half of Day One – a discussion entitled “Patients’ Perspective on Treatment Approaches” The FDA Drug Development Workshop for chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) took place on the 25th and 26th of April 2013. It was well attended by patients, advocates, doctors,
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FDA Drug Development Workshop: Part One
by Joel (snowathlete) and Gabby (Nielk) The FDA Drug Development Workshop for chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) took place last week on the 25th and 26th of April. It was well attended by patients, advocates, doctors, representatives of the CDC and even a few pharmaceutical reps. The workshop was also broadcast live over the internet, enabling many
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Historic FDA Stakeholder Meeting on ME/CFS, April 25-26: How To Have Your Say
As the FDA Stakeholder Meeting approaches, we explore the various ways that patients can get involved – and offer some suggestions on how to make the most of this unprecedented opportunity. On April 25-26, 2013, the United States Food and Drug Administration (FDA) is holding a workshop in Bethesda, MD to discuss how best to facilitate and expedite the development
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Bob Miller on Hunger Strike: Send This 1-Minute Email to Get FDA Approval for Ampligen
by Sasha Bob Miller has started a hunger strike to push for FDA approval of Ampligen. He and his wife, Courtney Alexander, who are well-known for drawing President Obama’s attention to the plight of people with ME/CFS, urge us not to do the same. Instead, they’d like us to send the email below, alerting key decision-makers to his strike, to
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URGENT: Email the FDA about Ampligen now and daily – final decision is imminent
by Sasha “There comes a point in human suffering when acceptable risk is most appropriately determined for oneself, not by government.” So said Suzy, in an online comment about the failure of the FDA Advisory Committee on Ampligen to vote in a manner that would have got approval for the drug’s use for patients with ME/CFS. But it’s not too
ContinueMake Room on Your Calendar 20 Dec for the Live Webcast of the FDA Ampligen Hearing
Try to leave your calendar open from 8am-5pm EST on the 20th for the FDA’s hearing in Ampligen! Information about the meeting is available at December 20, 2012 Meeting of the Arthritis Drugs Advisory Committee (not mistitled!). The webcast will take place at https://collaboration.fda.gov/aac122012/ and Phoenix Rising will attempt to embed the video locally to make it easier to simultaneously
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