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.
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.
The new kind of meeting is one of a number of changes that will be implemented as part of the...
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