Meeting Materials NOW Available! – NASACORT AQ

Posted by on July 29, 2013

July 31, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Nonprescirption Drugs Advisory Committee
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AdComm Roll Call Special – Spotlight on: CRDAC

Posted by on July 26, 2013

Much like ODAC, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) is another somewhat infamous FDA advisory committee. CRDAC is charged with reviewing and evaluating the safety and effectiveness of marketed and investigational drugs for use in the treatment of cardiovascular and renal disorders. 
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FDA Panel Votes Against Humira for Spinal Arthritis

Posted by on July 25, 2013

The RESULTS are in!
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Meeting Materials NOW Available! – HUMIRA

Posted by on July 19, 2013

July 23, 2013 8:00 a.m. to 5:30 p.m.: Arthritis Advisory Committee Meeting  Please click 
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Merck’s Sugammadex Delayed Again at FDA

Posted by on July 17, 2013

U.S. health regulators need more time to review Merck & Co’s application to sell sugammadex, an injection designed to reverse the effects of muscle relaxants used during surgery. 
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FDA Panel Recommends Alosetron REMS Should Include e-Prescribing

Posted by on July 12, 2013

The RESULTS are in!  A panel of the US Food and Drug Administration (FDA) has voted to switch to electronic prescribing for alosetron hydrochloride in addition to retaining and refining other aspects of the current risk management system that restricts its availability. Alosetron hydrochloride (LOTRONEX), manufactured by Prometheus Laboratories, Inc, is the only drug that
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Meeting Materials NOW Available! – LOTRONEX

Posted by on July 8, 2013

July 10, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Drug Safety and Risk Management Advisory Committee Meeting 
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Meeting Announcement – ADEMPAS

Posted by on July 8, 2013

August 6, 2013 8:00 a.m. to 4:00 p.m.: Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
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FDA AdComm Roll Call – 11 Vacancies on the Nonprescription AdComm?

Posted by on July 2, 2013

This month we saw the departure of 4 members of the Nonprescription Drugs Advisory Committee (NDAC) – which is a lot when you only had 6 members to begin with! Drs. Neil Farber, Walid Gellad, Marcus Reidenberg and Consumer Representative Lorna Totman have all reached the end of their terms. Estela Pledge, M.S., a Health Education
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FREE Quarterly Giveaway Now Available for Download!

Posted by on July 1, 2013

The Importance of Mock FDA Drug Advisory Committee Meetings: Proven Benefits, Proven Results Innovative Science Solutions (ISS) has over a decade of experience in preparing teams for FDA Advisory Committee (AdComm) meetings. One of the things we stress most to our clients is the importance of having at least two “mock” rehearsals. Why?
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