Documents, Articles, and Links

IMPORTANT RU-486 FILINGS with FDA:

• Citizen Petition (filed by American Association of Pro-Life Obstetricians and Gynecologists ("AAPLOG"), Christian Medical Association ("CMA"), Concerned Women for America ("CWA") on August 20, 2002)

• Response to Danco (filed by AAPLOG, CMA & CWA on October 10, 2003)

IMPORTANT FDA DOCUMENTS and WEBPAGES:

FDA Documents and Webpages Related to Current RU-486 Use

• Subpart H Drugs ("Accelerated Approval")

• Mifeprex Label (7/19/2005)

• Patient Agreement (7/19/2005)

• Medication Guide (7/19/2005)

• Prescriber Agreement (9/28/2000)

• Patient Information Sheet [PDF] (7/20/2005)

• Healthcare Professional Sheet [PDF] (11/9/2005)

• Public Health Advisory (updated 11/4/2005)

• FDA Question and Answer (11/4/2005)

FDA Documents and Webpages Related to the RU-486 Approval (Sept. 2000)

• Historical Documents/Information Issued by FDA Regarding Mifepristone

• Mifepristone Review (9/28/2000) (Pre-approval FDA documents)

• Office Memo to Population Council (9/28/2000)

• Federal Register (12/2/1992): Final Rule (Subpart H)

RELATED NON-FRC RU-486 WEBSITES:

• American Association of Pro-Life Obstetricians and Gynecologists ("AAPLOG")

• Christian Medical Association ("CMA")

• Concerned Women for America ("CWA")

• RU486Facts.org

• National Right to Life

LINKS TO ARTICLES AND PUBLICATIONS:

• Byron Calhoun, M.D. and Donna Harrison, M.D., "Challenges to the FDA Approval of Mifepristone," Annals of Pharmacotherapy (2004).

• Ralph P. Miech, "Pathophysiology of Mifepristone-Induced Septic Shock Due to Clostridium sordellii," Annals of Pharmacotherapy (published online July 26, 2005).

• Margaret M. Gary, M.D., and Donna J. Harrison, M.D., "Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient," Annals of Pharmacotherapy (published online December 27, 2005).