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Post# of 426493
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rafunrafun

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rafunrafun

Re: VuBru post# 213325

Monday, 09/09/2019 6:08:03 PM

Monday, September 09, 2019 6:08:03 PM

Post# of 426493
V - Does it not bother you that there do not seem to be any laws / policies / regulations that the FDA need to comply with?

Does the FDA need to comply with the PFUFA date?
-Nope.

How much of a notice must the FDA give a sponsor before an ADCOM?
-However much or little they please.

How far away from the PDUFA date must the ADCOM be?
-However much or little they please.

How many times can the PDUFA date be delayed?
-However many times FDA pleases to delay.

How soon after the standard/priority review decision must the ADCOM be decided?
-Whenever the FDA pleases.


This is just ridiculous. FDA are the almighty.
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