SUMMARY: As a new generation of directly targeted antiviral drugs for hepatitis C virus (HCV) infection approach the final stages of development, the U.S. Food and Drug Administration (FDA) is considering how to provide pre-approval expanded access for people with unmet medical needs, as is done with HIV drugs. The agency is current requesting comments and will hold a public hearing on April 30 near Washington, DC.
I just went to the web site and copied the following:
The public hearing will be held April 30, 2010, from 9 a.m. to 4 p.m. The meeting may be extended or may end early depending on the level of public participation. Submit written or electronic requests for oral presentations and comments by April 8, 2010 (see section III of this document for details).
Written or electronic comments will be accepted after the hearing until June 25, 2010 (see section V of this document for details).
The public hearing will be held at the Hilton Hotel, 1750 Rockville Pike, Rockville, MD 20852. Additional information on parking and public transportation may be accessed by contacting the hotel at 301-468-1100 or through the hotel's web page at http://www.rockvillehotel.com.
Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number found in brackets in the heading of this document [Ed. Note: Docket No. FDA-2010-N-0107]
Transcripts of the hearing will be available for review at the Division of Dockets Management and on the Internet at http:// www.regulations.gov approximately 45 days after the hearing (see section VI of this document).
FOR FURTHER INFORMATION CONTACT:
Susie Dill, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6183, Silver Spring, MD 20993-0002, 301-796-3437, FAX: 301-847-8753, e-mail: ***@****.
thanks for posting Bill. Promising sign. Looks like the *long* winter wait may finally be coming to an end. The vx phase 3 expected final data by the end of this month but they said they weren't filing till June and I was starting to suspect some glitch had come up.
This seems a great opportunity to let the FDA know (a) how many non-responders/relapsers/ifn-intolerant etc. patients are waiting in the wings and have been shut out of the naive-only trials (b) by now Merck/Vertex/Roche have made it clear they will not cooperate on multi-drug cocktails from different vendors; the FDA needs to authorize a process that will allow such trials to go forward.
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