Regulatory processes from Industry/FDA Statisticians’ perspectives
View Presentation *Hope Knuckles, Abbott Laboratories, NIC-ASA *Marina Kondratovich, FDA-CDRH Keywords: A case study will be presented displaying both the FDA and Industry perspective. In this case study, this team of FDA and Industry statisticians learned to communicate by listening and welcoming feedback. The Industry team elicited feedback from the FDA in the form of a Pre-IDE, and the FDA also gave additional feedback in the form of questions after the submission had occurred. Teleconferences enhanced industry's understanding through two-way conversations, promoting quick resolution of important issues that through paper would have taken longer; by listening to FDA and by incorporating their feedback, subsequent submissions were more successful. By creating a respectful relationship of trust and understanding expectations, this Industry team has been able to apply these expectations and receive appropriate direction from the FDA.
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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