Regulatory processes from Industry/FDA Statisticians’ perspectives
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*Hope Knuckles, Abbott Laboratories, NIC-ASA  *Marina Kondratovich, FDA-CDRH 


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.