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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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Essential First Steps to FDA 505(b) (2) Drug Approval | |
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January 23, 2008 |
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Drug Information Association, Online
Feb 19 2008
Today, start-up and small pharmaceutical companies use the FDA's 505(b)(2) approval pathway to modify and reposition existing drugs for more predictable, lower risk, and less costly marketing clearance. Similar to a 505(b)(1) submission for new molecular entities, 505(b)(2) requires the submission of a full NDA. This 90-minute webinar will teach you why and how a properly submitted 505(b)(2) can be the difference between success and failure of a new drug approval.
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Organized by:
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Drug Information Association |
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Invited Speakers:
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KENNETH PHELPS, PresidentCamargo Pharmaceutical Services.
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Deadline for Abstracts:
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-
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Registration:
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http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16547&eventType=Webinar
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E-mail:
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dia@diahome.org
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