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Thursday, June 27, 2019 4:19:08 PM
Here:
https://www.fda.gov/media/75436/download Page 19
The 55 day notice is so Amarin can prepare for reasons why Ad Com need.
Amarin has not been notified.
Ad Com must occur 6 weeks before priority review. 21st Century Cure Act is mostly about timely FDA communications...several Ad Com references.
BB
https://www.fda.gov/media/75436/download Page 19
For open advisory committee meetings that involve sponsor-prepared briefing materials, approximately 55 business days before the meeting is scheduled to occur, FDA intends to notify a sponsor that an advisory committee will consider an issue that is directly relevant to the sponsor.
The 55 day notice is so Amarin can prepare for reasons why Ad Com need.
Amarin has not been notified.
Ad Com must occur 6 weeks before priority review. 21st Century Cure Act is mostly about timely FDA communications...several Ad Com references.
BB
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