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, 2010

Time:       9:00 a.m. to 4:00 p.m. 

Location:  Hilton Hotel, 1750 Rockville Pike, Rockville, MD 20852 
 

• Agenda (PDF - 28KB)
• Meeting Transcript (PDF - 543KB)
• Slide Presentations (available on the regulations.gov web site)
• Federal Register Notice of Public Hearing (PDF - 55KB) (issued 3/10/2010)