What's with these FDA dates being on Sundays and holidays?

Billy · 05-31-2009, 02:43 PM

ABIO's date is expected to be today (Sunday) and HEB's original date was on 5/25 (Memorial Day). What gives?

Kordoyn · 05-31-2009, 03:52 PM

They just give a date 6 or 12 months from filing date, or 3 months from a 'delay' announcement. I don't think they actually look on a calendar as to what day those land on. If it's a holiday or whatever it's probably understood that the deadline is the next working day.

Billy · 05-31-2009, 03:55 PM

Does the FDA have set in stone rules about giving a response on those time frames you just mentioned, or are these just ballpark estimates?

Kordoyn · 05-31-2009, 04:11 PM

As far as I know they must issue some sort of response within the time frame. Whether it's an approval, denial, extension or whatever.
Someone mentioned in the HEB thread that by law they have to give some sort of response by the date, whether that is accurate I'm not sure.

05-31-2009, 02:43 PM	#1
Billy Trader Join Date: May 2009 Location: Corpus Christi Posts: 52 Favorites: heb dndn vnda Rep Power: 28 Reputation: 297	What's with these FDA dates being on Sundays and holidays? ABIO's date is expected to be today (Sunday) and HEB's original date was on 5/25 (Memorial Day). What gives?

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05-31-2009, 03:52 PM	#2
Kordoyn UberTrader Join Date: May 2009 Location: TOronto Posts: 383 Favorites: DOW TCK HEB Rep Power: 168 Reputation: 3456	They just give a date 6 or 12 months from filing date, or 3 months from a 'delay' announcement. I don't think they actually look on a calendar as to what day those land on. If it's a holiday or whatever it's probably understood that the deadline is the next working day.

05-31-2009, 03:55 PM	#3
Billy Trader Join Date: May 2009 Location: Corpus Christi Posts: 52 Favorites: heb dndn vnda Rep Power: 28 Reputation: 297	Does the FDA have set in stone rules about giving a response on those time frames you just mentioned, or are these just ballpark estimates?

05-31-2009, 04:11 PM	#4
Kordoyn UberTrader Join Date: May 2009 Location: TOronto Posts: 383 Favorites: DOW TCK HEB Rep Power: 168 Reputation: 3456	As far as I know they must issue some sort of response within the time frame. Whether it's an approval, denial, extension or whatever. Someone mentioned in the HEB thread that by law they have to give some sort of response by the date, whether that is accurate I'm not sure.