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U.S. Department of Health and Human Services

Advisory Committees

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Briefing Information for the September 9, 2011 Joint Meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

 

Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance
 
 
FDA
 
Disclaimer
 
Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. § 552).
  
FDA Briefing Information for the September 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 2.13MB)
 
Addendum to the FDA Briefing Information for the September 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 2.13MB)
 
 
Merck & Co., Inc
 
Disclaimer
 
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
 
Merck Briefing Information for the September 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 468KB)
 
 
Warner Chilcott, LLC
 
Disclaimer
 
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
 
Warner Briefing Information for the September 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 374KB)
 
 
Roche Therapeutics, Inc
 
Disclaimer
 
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
 
Roche Briefing Information for the September 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 243KB)
 
 
 Novartis Pharmaceuticals Corporation
 
Disclaimer
 
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
 
Novartis Briefing Information for the September 9, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF – 4.61MB)