The Role of Regulatory Affairs in Preparing for NDA Interactions

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.

KEY TOPICS

• Executive Summary
• Starting with the NDA
• Who Speaks, Leads
• Working with the Project Manager
• Preparing for NDA Meetings
• Meeting Rehearsals
• Negotiating for a Win-Win with Labeling

• Top Methods for Working with the FDA
• Effectiveness Rating of Interaction Approaches
• Groups and Roles during the NDA Process
• Use of Expert/Outside Consultant
• Effectiveness Rating of Preparation Approaches for Advisory Committee Meetings
• Ranking of Top Three Preparation Approaches for Advisory Committee Meetings

• Develop flexible negotiation skills that identify key points to defend and preserve in the NDA – and create flexible options for compromise on nonessential issues or on non-negotiable issues such as public safety. Look for win-win solutions.
  
• Draft label submission can represent opportunity or risk so organizations need to balance aspiration and realism. Early interactions with the FDA can help accelerate or slow your NDA process.

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