Hepatitis C Support Group
Hepatitis C is a blood-borne viral disease which can cause liver inflammation, fibrosis, cirrhosis and liver cancer. The hepatitis C virus (HCV) is spread by blood-to-blood contact with an infected person's blood. Many people with HCV infection have no symptoms and are unaware of the need to seek treatment. Hepatitis C infects an estimated 150-200 million people worldwide.
Connecting Patients With Experimental Drugs
FDA Program Gives Seriously Ill People Path to Obtain Drugs Still in Testing; One Woman's Brush With Death
http://online.wsj.com/article/SB10000872396390444592704578062640104322714.html
FDA Program Gives Seriously Ill People Path to Obtain Drugs Still in Testing; One Woman's Brush With Death
http://online.wsj.com/article/SB10000872396390444592704578062640104322714.html
I think you found something that will help me and Marylyn in getting to the front of the line in waiting for the new drug Daclatasvir with this article and I thank you sooo much for posting it here!!!
From this article, I found out who to contact (Richard Klein) in the FDA, his contact information so, I'll post it here and in another thread so that those of us who do need to take advantage of this, do so in a timely manner...
The person to contact in the hopes of getting to try the new drugs coming out but not yet approved by the FDA is:
Richard Klein, Director of the Food and Drug Administration's Office of Special Health issues (OSHI),
White Oak, Building 32
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone # 301-796-8460
I'm going to follow up on this ASAP and will make sure tha Marylyn gets this information as well and I'm going to post a petition in order to get enough signatures to send this person so that both Marylyn and myself have a better chance in receiving this help from the FDA and the folks @ Bristol Myers...
Once again, thanks for the article! Oh and I almost forgot, here's the .pdf with the contact info:
http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/OOPDNewsArchive/UCM292729.pdf
Here's another important link or two of the FDA also:
http://www.fda.gov/downloads/AboutFDA/Basics/UCM202331.pdf
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194958.htm
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm200769.htm
Here's a webinar on expanded access/compassionate use system of the FDA:
https://webmeeting.nih.gov/p14874544/
The presentation slides:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194958.htm
Well, that all I found so far...
Respectfully,
Henry