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Re: KCSVEN post# 15224

Tuesday, 10/01/2013 11:38:41 AM

Tuesday, October 01, 2013 11:38:41 AM

Post# of 426290
Found this on Adcomm's from raps.org website:

In addition, it remains to be seen if FDA's advisory committees—essential for the review of new molecular entities and high-risk medical devices—would be convened according to schedule, or if they would be postponed. Advisory committee members are technically "special government employees," and might not be seen as "essential" under the law.

And then this note from Fierce Biotech:

"Of course, the scope of the word "limited" remains unexplained, and the agency isn't in a position to be terribly specific about where advisory committees fit in. "Generally speaking, these meetings would continue in some way," an FDA spokesperson said in an email to FierceBiotech on Monda


So I think its unclear on Adcomm's though many PDUFA require Adcomm's so perhaps they are funded similarly with fees and the FDA spokesperson saying they will CONTINUE IN SOME WAY seems to indicate AMRN is all set but what does "some way" mean? By conference call instead of paying to fly people in etc...? Couldn't AMRN offer to pick up the cost of the Adcomm as a user fee if it came to that? Seems based on FDA email Adcomm will go on and PDUFA is 100% clear will go on.
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