Re: ACOG/Cytotec -good news

From: Braun, R. Daniel (rbraun@iupui.edu)
Wed Nov 1 13:48:33 2000


Nothing, they don't have any reason to take any action. The manufacturer has not requested any changes in labelling. No one has presented them with any studies showing that anything is wrong with the current labelling. There are not enough studies of the appropriate kind to get induction ofl labor added as an indication. If they even bother to respond, they will say OK, so what? Of course like Art, "I could be wrong." And I will be glad if I am.

Dan

-----Original Message----- From: Paul Prior MDTo: Multiple recipients of list OB-GYN-L Sent: 10/31/00 9:25 PM Subject: Re: ACOG/Cytotec -good news

On Tue, 31 Oct 2000 19:06:41 -0600, eramirez@icepr.com (Efrain Ramirez) wrote:

>ACOG NEWS RELEASE
>
> For Release: October 27, 2000
>
>ACOG Writes FDA on Safety of Misoprostol

..deleted...

By my initial read, this appears to be a balanced and reasoned response. I am pleased that it was done promptly and hope that all of our phone calls perhaps aided in this process in some way.

Anyone have a sense of what the FDA will do on this?

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