FDA AdComm Roll Call – 4 New Members!!

Posted by on December 6, 2013

For this edition of our FDA AdComm Roll Call, 4 new individuals have been welcomed into two advisory committees!!
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Meeting Materials NOW Available! – vedolizumab

Posted by on December 5, 2013

December 9, 2013 8:00 a.m. to 5:30 p.m.: Joint Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting 
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FDA Panel Recommends Vimizim for Approval

Posted by on November 21, 2013

On Tuesday, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor of approval of Vimizim for the treatment of Mucopolysaccharidosis Type IVA (MPS IVA) or Morquio A syndrome. Nineteen of the 21 panel members supported approval of Vimizim for use in all MPS IVA patients; one voted in favor of approval for a subgroup
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FDA Supports tasimelteon for Sleep Regulation Disorder

Posted by on November 15, 2013

Yesterday, the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee overwhelmingly voted in favor of recommending approval of Vanda’s New Drug Application (NDA) for tasimelteon, proposed tradename HETLIOZ™. Tasimelteon is designed for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in blind individuals. 
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FDA AdComm Roll Call – New Members!

Posted by on November 15, 2013

This month we saw the departure of seven members and the addition of a total of 15 new members to the FDA Drug Advisory Committees. The committees that welcomed new members include the Anesthetic Drug Products Advisory Committee (AADP), the Antiviral Drugs Advisory Committee (AVD), the Pharmaceutical Science and Clinical Pharmacology Advisory Committee, and the
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Meeting Materials NOW Available! – Vimizim (elosulfase alfa)

Posted by on November 15, 2013

November 19, 2013 8:00 a.m. to 5:00 p.m.: Endocrinologic and Metabolic Drugs Advisory Committee Meeting
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AdComm Roll Call Special – Spotlight on: Arthritis Advisory Committee

Posted by on November 14, 2013

The Arthritis Advisory Committee (AAC) has the responsibility of reviewing and evaluating data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of arthritis, rheumatism, and related diseases. Based on this evaluation, the committee makes appropriate recommendations to the Commissioner of Food and Drugs regarding the future
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Meeting Announcement – vedolizumab injection

Posted by on November 14, 2013

December 9, 2013 8:00 a.m. to 5:30 p.m.: Joint Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement
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Meeting Announcement – metreleptin

Posted by on November 14, 2013

December 11, 2013 7:45 a.m. to 5:00 p.m.: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
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Meeting Announcement – dapagliflozin tablet

Posted by on November 12, 2013

December 12, 2013 8:00 a.m. to 5:00 p.m.: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
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