FDA Schedules Public Hearing on Expanded Access for Direct-acting Antiviral Agents for Chronic Hepatitis C

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FDA Schedules Public Hearing on Expanded Access for Direct-acting Antiviral Agents for Chronic Hepatitis C

SUMMARY: With a new generation of directly targeted antiviral drugs for hepatitis C virus (HCV) nearing 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. The FDA announced earlier this month that it is accepting comments regarding expanded availability. The agency has now provided further information about a public hearing to address the issue, to be held on April 30, 2010.

Below is a recent announcement from the FDA regarding the public hearing.

Public Hearing on Expanded Access of Direct-Acting Antiviral Agents (DAAs) for the Treatment of Chronic Hepatitis C Infection in Patients with Unmet Medical Need

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on the scope and implementation of potential Expanded Access programs with Direct-Acting Antiviral Agents (DAAs) for the treatment of Chronic Hepatitis C (CHC) infection in patients with unmet medical need. The public hearing is being held to obtain comments from the public on eligibility criteria that should be used for patient enrollment into expanded access protocols and to elicit suggestions for designs of Treatment IND protocols and other expanded access protocols. In addition the agency would like public input on types of studies that should be conducted to obtain information on patients with the greatest risk of progression of liver disease and/or the lowest predicted virologic response rates.Please see the Federal Register notice (below) for information on submitting written or

electronic comments and requests to make oral presentations at the hearing.

Date: April 30, 2010Time: 9:00 a.m. to 4:00 p.m. Location: Hilton Hotel, 1750 Rockville Pike, Rockville, MD 20852 Federal Register Notice of Public Hearing (issued 3/10/2010)

3/30/10

SourceFood and Drug Administration. Public Hearing on Expanded Access of Direct-Acting Antiviral Agents (DAAs) for the Treatment of Chronic Hepatitis C Infection in Patients with Unmet Medical Need. E-mail announcement. March 26, 2010.

http://www.hivandhepatitis.com/hep_c/news/2010/033010_a.html