From: S.Mayer@organonusa.com
Sent: Thursday, March 20, 2003 1:53 PM
To: fdadockets@oc.fda.gov
Subject: Dockets No. 03D-0007 Estrogen Progestin Drug Product to Treat
Vas omotor Symptoms

Dockets Number 03D-0007 Draft Guidance entitled, " Estrogen Progestin Drug
Product to Treat Vasomotor Symptoms"


	Regarding the issue of endometrial biopsies, is the testing relevant
for Phase I, Phase II and Phase III trials with the product under
investigation or, is it the Agency's intent that biopsies be taken only in
the latter phase (Phase II/III and Phase III) of product development. 

Susan Mayer
Regulatory Affairs
Organon Inc.
375 Mount Pleasant Ave.
W. Orange, NJ 07052
(T) 973-325-5224
(F) 973-669-6289
E-mail: s.mayer@organonusa.com


===============================================================================

This message, including attached files, may contain confidential information and is intended only for the use by the individual and/or the entity to which it is addressed.  Any unauthorized use, dissemination of, or copying of the information contained herein is not allowed and may lead to irreparable harm and damage for which you may be held liable.  If you receive this message in error or if it is intended for someone else please notify the sender by returning this e-mail immediately and delete the message. 

===============================================================================