Sunday, December 5, 2010

FDA seeking new members with Hepatitis C experience

FDA Hepatitis Update - FDA seeking new members with Hep C experience for its Antiviral Drugs Advisory Committee

Drugs Advisory Committee
Subject: FDA Hepatitis Update - FDA seeking new members with Hep C experience for its Antiviral Drugs Advisory Committee
From: "U.S. Food & Drug Administration (FDA)"
Date: Sat, 4 Dec 2010 23:46:40 -0600 (CST)

-------------------------------------------------------------------------

Title: FDA Hepatitis Update - FDA seeking new members with Hep C experience for its Antiviral Drugs Advisory Committee
You are receiving this message as a subscriber to the FDA hepatitis electronic list serve. The purpose of the list serve is to relay important information about viral hepatitis-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

The Food and Drug Administration (FDA), to assist in its mission to protect and promote the public health, uses 49 committees and panels to obtain independent expert advice on scientific, technical, and policy matters.

FDA is seeking technically qualified medical/scientific consultants to serve as members of its Antiviral Drugs Advisory Committee for future panels to consider potential direct-acting antivirals (DAAs) for the treatment of hepatitis C - specifically hepatologists or other medical doctors who treat a substantial number of hepatitis C patients. Consultants should have experience interpreting and analyzing detailed scientific data, and understand its public health significance.

Potential candidates will be required to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. Potential conflicts include, but may not be limited to: employment with a pharmaceutical sponsor, having financial interests or stock in pharmaceutical companies developing DAAs, participating as an investigator in pivotal studies of DAAs in development, being chair of a department in which colleagues are investigating a DAA, or receiving substantial amounts of reimbursement from DAA sponsors for consulting services or presentations.

Advisory Committee meetings are convened in the Washington DC metropolitan area, typically for two days twice a year. Committee members are appointed as Special Government Employees, and receive a salary for each meeting day as well as travel and per diem costs.

General information about FDA Advisory Committees can be found at http://www.fda.gov/AdvisoryCommittees/default.htm
and information about membership can be found at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/CommitteeMembership/default.htm

If you are a medical doctor meeting the criteria above, or would like to nominate a medical doctor with hepatitis C expertise, You may submit your information by:

Food and Drug Administration
Advisory Committee Oversight and Management Staff
10903 New Hampshire Avenue, Bldg. 32, Rm. 5101
Silver Spring, Maryland 20993-0002
Please include full contact information of any person you are nominating.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

No comments:

Post a Comment