The next three FDA Hearings that CVN will webcast live are:
APR 27-28: Antiviral Drugs Committee applications for the Hepatitis C treatments Boceprevir (Merck) and Telaprevir (Vertex).
MAY 12: Orthopaedic Devices Panel application for the premarket approval of Augment Bone Graft (Biomimetic).
JUN 29: Microbiology Devices Panel classification of TB rapid detection tests.
Additional details are below. Subscribe to CVN and watch FDA panel hearings both live and on-demand from your office.
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Antiviral Drugs Advisory Committee
On April 27, 2011, the committee will discuss a new drug application (NDA) 202-258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
On May 12, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Augment Bone Graft, sponsored by Biomimetic Therapeutics, Inc. The intended use of the device is as an alternative bone grafting substitute to autologous bone graft in applications to facilitate fusion in the ankle and foot without necessitating an additional invasive procedure to harvest the graft.
Microbiology Devices Panel of the Medical Devices Advisory Committee
On June 29, 2011, the committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex.
The Food and Drug Administration, to assist in its mission to protect and promote the public health, uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters. The FDA has 32 advisory committees, one of which, the Medical Devices Advisory Committee, has 18 panels.
Subscribe to CVN and watch selected FDA panel hearings both live and on-demand from your office or anywhere.