2014 Advisory Committee Tentative Meetings

[ashiwi]

No date set yet for Endocrinologic and metabolic drugs.
My fear is since April 1 was "tentative" date for Ad Comm, it could also be scheduled at a later date which would push back PDUFA date. 
I signed up for e-mail alerts when there are new updates fro the FDA.

www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm

Endocrinologic and Metabolic Drugs Advisory Committee


Date(s), if needed, to be determined

[otherottawaguy]

Ashiwi:

As I have come to understand, a firm Scheduled date is required to be announounced NLT 15 days prior to the Tentative date, ergo by mid March we should will know if its a go or not.

And then let the pre PUFDA fireworks begin.

OOG

[alcc]

Huh? So it's not the date of the adcom that's tentative but the meeting itself?? In other words, fda may yet decide none is needed? Don't they need time to develop the briefing doc (as we speak) and allow time for adcom members to review and digest the doc prior to mtg?

[babaoriley]

No, I just think it's the date that is uncertain, I think there will certainly be an AdCom.

[rak5555]

I agree w/ baba. You may recall management saying they were not surprised when adcom was announced. This was likely based on the nature of ongoing discussions w/ FDA