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2006P-0348: Amend the Vancomycin HCl Package Insert to Reflect Modifications of the Antimicrobial Susceptibility Interpretive Criteria to Better Recognize Emerging Resistance Resulting in Compromised Patient Outcomes

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
CP1 08/23/2006 08/24/2006 Private Industry Clinical and Laboratory Standards Institute       pdf
Attachments
 
Signature: Robert Habig, PhD and Glen Fine, MS
ACK1 08/24/2006 08/24/2006 Federal Government FDA/DDM to Clinical and Laboratory Standards Institute       pdf  
Signature: Lyle D. Jaffe
EC1 08/31/2006 08/31/2006 Individual Consumer Mr. Dave Lowe       htm  
C1 09/14/2006 09/11/2006 Health Care Association Society of Infectious Diseases Pharmacists (SIDP)       pdf  
Signature: THomas C. Hardin, PharmD., MBA, FC
EC2 09/15/2006 09/14/2006 Health Care Association Infectious Diseases Society of America       pdf  
  Signature: Blaser, Martin
EC3 09/18/2006 09/17/2006 Individual Consumer Mr. Dave Lowe       htm
Attachment
 
EC4 09/19/2006 09/18/2006 Health Care Association Infectious Diseases Society of America       pdf  
  Signature: Blaser, Martin J.

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