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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Meeting Announcement – NASACORT AQ Rx to OTC Switch

Posted by on June 27, 2013

July 31, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Nonprescription Drugs Advisory Committee Announcement
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Meeting Announcement – TOLVAPTAN

Posted by on June 19, 2013

August 5, 2013 8:00 a.m. to 5:30 p.m.: Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement  
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Meeting Announcement – HUMIRA

Posted by on June 10, 2013

FDA panel favors alleviating restrictions for AVANDIA

Posted by on June 10, 2013

The RESULTS are in! A panel of FDA advisers thinks it is time to alleviate restrictions currently in place for the antidiabetic drug, Avandia (rosiglitazone). Of the 20 panelists who voted to remove or modify the current labeling and distribution center, 13 voted to modify it while the remaining 7 voted to remove the REMS
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FDA Drug Advisory Committee – Changes to DSaRM and more!

Posted by on June 7, 2013

At ISS we know the importance of understanding your audience at an FDA AdComm – what are their backgrounds, are they motivated by a particular cause or issue? Based on our knowledge we are happy to kick-off the ISS roll call blog – a designated reporter of the changes to the FDA Drug AdComm members.
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CANCELLED Meeting Announcement – SUGAMMADEX

Posted by on June 7, 2013

July 18, 2013 8:00 a.m. to 5:00 p.m.:  Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
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Introducing: The ISS FDA AdComm Roll Call – Who’s on the Roster??

Posted by on June 6, 2013

“Who’s new to the committees?” “Is there a new Chair?” “What is that member’s specialty?” At Innovative Science Solutions we understand the importance of “knowing” the committee. The members of the FDA AdComms are your audience – how well do you know who you are speaking to? Subscribe to the ISS FDA AdComm Blog and
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CANCELLED Meeting Announcement – MOXDUO

Posted by on June 6, 2013

July 17, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
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