FDA | New draft guidance for PDUFA products

October 11, 2023

The US Food and Drug Administration (FDA) has released an updated preliminary advisory document aimed at assisting sponsors in comprehending the various categories of meetings they can seek to address inquiries related to their applications, while also outlining the timeframes associated with these requests.

The guidance adds two new types of meetings, a Type D meeting for topics of narrow interest and meetings through the INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) pathway for new and innovative technologies. It also now classifies video conference meetings as virtual face-to-face meetings.

This draft guidance, when finalized, will represent the current thinking of the Agency on this topic. Read the full guidance HERE.

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