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Best Practice Database
Quality, Compliance and Regulatory » Regulatory Affairs
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Positive working relationships with FDA officials can help an NDA progress efficiently through the regulatory process. Lack of good communication can drag out a submission or, potentially, doom it. Regulatory Affairs leaders face a plethora of responsibilities but one of the most important is helping prepare a company’s team for NDA-related meetings.
This study examines the role of Regulatory Affairs groups in helping the NDA navigate FDA’s process and preparing development teams for interactions with regulators and advisory committees.
Regulatory leaders can use the insights from this research to compare and adjust their group’s approach to interactions with the FDA.