lunes, 25 de abril de 2011

FDA Hepatitis Update - April 27, 2011 FDA Advisory Committee background materials available: boceprevir for Hep C || Advisory Committee Calendar > April 27, 2011: Antiviral Drugs Advisory Committee Meeting Announcement

FDA Hepatitis Update - April 27, 2011 FDA Advisory Committee background materials available: boceprevir for Hep C



Background materials for the April 27, 2011 FDA Antiviral Advisory Committee meeting to discuss boceprevir, a direct acting antiviral (DAA) intended for the treatment of hepatitis C, are available on the FDA web site through the following links...

April 27, 2011: Antiviral Drugs Advisory Committee Meeting Announcement : Advisory Committee Calendar > April 27, 2011: Antiviral Drugs Advisory Committee Meeting Announcement


Draft Agenda for the April 27, 2011 Meeting of the Antiviral Drugs Advisory Committee (PDF - 42KB) : http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252329.pdf


Draft Questions for the April 27, 2011 Meeting of the Antiviral Drugs Advisory Committee (PDF - 22KB) : http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252330.pdf


Draft Meeting Roster for the April 27, 2011 Meeting of the Antiviral Drugs Advisory Committee (PDF - 64KB) : http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252332.pdf


Committee Roster for the April 27, 2011 Meeting of the Antiviral Drugs Advisory Committee (PDF - 25KB) : http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252334.pdf


Webcast Information for the April 27, 2011 Meeting of the Antiviral Drugs Advisory Committee (PDF - 16KB) : http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252336.pdf


Briefing Information for the April 27, 2011 Meeting of the Antiviral Drugs Advisory Committee : Antiviral Drugs Advisory Committee > Briefing Information for the April 27, 2011 Meeting of the Antiviral Drugs Advisory Committee

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


Advisory Committee Calendar > April 27, 2011: Antiviral Drugs Advisory Committee Meeting Announcement


see below:

Background Material for Boceprevir Advisory Committee
Division of Antiviral Products (DAVP)
April 27, 2011

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252341.pdf


Merck Briefing Information for the April 27, 2011 Meeting of the Antiviral Drugs Advisory Committee (PDF – 1.07MB)3
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252343.pdf

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