Beginning next fall, drug sponsors favorite letter might be “D.” That’s the term for the new type of meeting being created to help developers ask clarifying questions after a formal meeting with the US FDA.
When It Comes To Sponsor Meetings, FDA Is Getting A ‘D’
New ‘Type D’ meetings will be added as part of PDUFA VII, one of a spate of changes under the next version of the user fee program that will begin in October 2022.
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