Type of Posting: Revision Bulletin
Posting Date: 28–May–2010
Official Date: 01–Jul–2010
Expert Committee: Biopharmaceutics and Monograph Development—Pulmonary and Steroids
In accordance with the Rules and Procedures of the 2005–2010 Council of Experts, the Biopharmaceutics Expert Committee and the Monograph Development—Pulmonary and Steroids Expert Committee have revised the Estradiol Vaginal Inserts monograph. The purpose for the revision is to include new procedures and acceptance criteria for the 0.01 mg/insert formulation recently approved by the FDA.
The Estradiol Vaginal Inserts Monograph Revision Bulletin supersedes the currently official Estradiol Vaginal Inserts Monograph. The Revision Bulletin will be incorporated in USP 34–NF 29.
Should you have any questions, please contact Domenick Vicchio, Ph.D. (301-998-6828 or DWV@usp.org).