Pharmababble - Latest Comments in FDA Likes Promacta

Re: FDA Likes Promacta

will — Mon, 09 Jun 2008 08:56:04 -0000

I believe it was the FDA reviewer, not the advisory panel, that posted the negative remarks ahead of the panel meeting. Anyone else have any thoughts on the chances of Promacta being approved?

Re: FDA Likes Promacta

alex — Fri, 06 Jun 2008 15:52:26 -0000

thank you

Re: FDA Likes Promacta

TheEben — Fri, 06 Jun 2008 13:43:04 -0000

Well, not every drug goes through the advisory committee for a
recommendation but:
Confirmed 2008 calendar:
http://www.fda.gov/oc/advis...
Tentative dates:
http://www.fda.gov/oc/advis...

I'll write a post on the approval process in the next day or so... that
might help more.

Re: FDA Likes Promacta

alexcampbello — Thu, 05 Jun 2008 22:51:27 -0000

hello, there is a calendar for the meeting of the scientific advisory committee posted by FDA,
Where can we find the calendar for FDA meeting to approve or reject the
NDA ? Would you please post the website of the FDA calendar for this NDA meeting.

Thanks

Re: FDA Likes Promacta

ely perez — Mon, 02 Jun 2008 13:29:52 -0000

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