TL16: Improving Communications Between FDA, Sponsor and Advisory Panel
*Gary Lynn Kamer, FDA/CDRH/OSB/DBS Keywords: The purpose of this session is to describe and discuss the general and specific tools for improved communications during the FDA submission process for new medical devices. The use of pre-meetings, appropriate submission content, and meaningful dialogue with the Advisory Panel will be discussed. Examples of poor and good communications will be given.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC