Specific Regulatory Initiatives

CDER Information on Conjugated Estrogens

• FDA's Current Position - Letter from Dr. Janet Woodcock, Director FDA/CDER

• FDA Background Information on Conjugated Estrogens

• Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence [HTML] or [Acrobat] (Issued 3/6/2000, Posted 3/6/2000)

• Conjugated Estrogens Monograph Materials submitted to the United States Pharmacopeia "Committee of Revision" for consideration for adoption:

1. Transmittal letter proposing the establishment of new monographs for "Synthetic Conjugated Estrogens, USP" and "Synthetic Conjugated Estrogens Tablets, USP" along with the proposed monographs

2. Transmittal letter proposing revisions to the current USP 24 monograph for "Conjugated Estrogens" along with the proposed monograph.

FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DML
HTML by  PKS