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Updated: 2008-11-10

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Annual Index: Current  
2007 Index: Fall 2007 Summer 2007 Winter/Spring 2007  
2006 Index: Fall 2006 Summer 2006 Winter/Spring 2006  
  2005 2004 2003
  2002 2001 2000
  1999 1998  

Current

Winter/Spring 2008

Fall 2007:

  • Updated (December, 2007) ORA Laboratory Manual, version 1.5 is now available online.
  • New and removed (November 8, 2007) in Compliance Reference: new Medical Device Program supersedes three other programs, now withdrawn.
  • Update (September 28, 2007) in Compliance References of the Regulatory Procedures Manual (RPM) has been revised:
    • Chapters 4 (Advisory Actions), 5 (Administrative Actions), and 6 (Judicial Actions) were revised to remove references to HFA-224.
    • Chapter 4 was further revised as follows:
      • Section 4-1-4 Center Concurrence and Letters Issued By Centers, Paragraph 5 Center for Veterinary Medicine (CVM), was revised to reflect the Regulatory/Administrative guidance in Compliance Program 7371.006:
        • Subparagraph b. was revised to read: "b. Tissue residue violations involving meat and poultry where no tolerance has been established, extra-label use is documented, and/or those which involve the use of compounded drugs or other drug adulteration;" and the footnoote in subparagraph b. that had allowed CVM to grant districts direct reference authority on a case-by-case basis was deleted.
        • New subparagraph c. was added to require CVM concurrence for:  "c.  Tissue residue violations involving aquacultured seafood, and other animal-derived products."
        • The remaining subparagraphs c-f were renumbered as d-g.
      • Section 4-1-18 Tracking; 1. Identification of Warning Letters was revised  to reference the use of the Compliance Management System (CMS) for Tracking Warning Letters.
      • New Section 4-2-2 Tracking; 1. Identification of Untitled Letters was added to reference the use of the CMS for tracking Untitled Letters.
  • Update (September 5, 2007) in Compliance Reference: revised entries for William K. Summers, MD, CA, in Restricted List for Clinical Investigators and Removed List for Clinical Investigators.

Summer 2007:

Winter/Spring 2007:


Fall 2006:

  • New (December 7, 2006) - American Red Cross/Biomedical Services, Washington, D.C., Consent Decree Correspondence, dated 11/15/2006 (regarding Adverse Determination Letter, paragraph X, dated 09/17/2006 ), in ORA Reading Room.
  • New (November 21, 2006) - American Red Cross/Biomedical Services, Washington, D.C., NYPR Adverse Determination Letter, dated 09/07/2006 in ORA Reading Room.
  • Updated (November 21, 2006) Federal-State Relations Small Business Guide Small Business Representatives and Regional Small Business Representatives
  • New (September 11, 2006) - American Red Cross/Biomedical Services, Washington, D.C., Adverse Determination Letter, dated 09/07/2006 in ORA Reading Room.

Summer 2006:

Winter/Spring 2006:

Annual Index: Current 2005 2004 2003
  2002 2001 2000 1999
        1998