Briefing Information for the January 24-25, 2013 Meeting of the Drug Safety and Risk Management Advisory Committee
Please note that the Briefing Material below may include references to the originally scheduled Drug Safety and Risk Management Advisory Committee meeting which was to take place on October 29-30, 2012. This originally scheduled meeting was postponed and rescheduled for January 24-25, 2013, due to unanticipated weather conditions caused by Hurricane Sandy.
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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).
Generic Pharmaceutical Association (GPhA)
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.