2005 Revisions and Updates

• 12/29/2005:
  Revised Restricted List for Clinical Investigators to add 1 new member
• 12/21/2005:
  Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990. Updated December 09, 2005
  Edited list to correct typographical error in the initial of Dr. Farber on Disqualified/Totally Restricted List for Clinical Investigators
  Updated "FDA AIP Contacts List" (December 2005) on the Application Integrity Policy Information page
• 12/12/2005:
  Revised CPG Sec. 230.150 - Blood Donor Classification Statement, Paid or Volunteer Donor
  Revised CPG Sec. 300.750 - Class III Devices Subject to 515(b) Requirements (CPG 7124.18)
  Revoked CPG Sec. 460.700 - Controlled Release Dosage Form Drugs - Rate of Release of Active Ingredients (CPG 7132a.02)
• 12/06/2005:
  Updated list to remove restriction for 1 member, 11/23/2005: Restricted List for Clinical Investigators
• 12/01/2005:
  Updated "FDA AIP Contacts List" (August 2005) on the Application Integrity Policy Information page
• 11/29/2005:
  Edited Compliance Policy Guides Sec. 160.100 and 118 pages in Chapter 5 to reflect FDA organization and contact changes.
• 11/18/2005:
  Added on-line link for compliance program 7385.014, Mammography Facility Inspections.
  Revised list to add 1 new member on Disqualified/Totally Restricted List for Clinical Investigators
• 11/14/2005:
  Revised list to add 1 new member, Disqualified/Totally Restricted List for Clinical Investigators
• 11/10/2005:
  Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
• 11/03/2005:
  Revised list to remove one member from the Application Integrity Policy List
• 10/31/2005:
  Revised http://www.fda.gov/ora/compliance_ref/bimo/disqlist.htm to add one person and update the list contact person. Also, the contact person was updated on:
  http://www.fda.gov/ora/compliance_ref/bimo/asurlist.htm
  http://www.fda.gov/ora/compliance_ref/bimo/restlist.htm
• 09/15/2005:
  Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated September 15, 2005
• 09/13/2005:
  Revised list to remove one member on the Application Integrity Policy List
• 08/08/2005:
  Revoked by Federal Register notice on 09/24/1998 (63 FR 51074), CPG Sec. 615.100 Extra-Label Use of New Animal Drugs in Food-Producing Animals (CPG 7125.06)
• 08/04/2005:
  Updated the program contact person (s) information on the following pages:
  http://www.fda.gov/ora/compliance_ref/bimo/default.htm
  http://www.fda.gov/ora/compliance_ref/bimo/background.html
  http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html
  http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html
  http://www.fda.gov/ora/compliance_ref/bimo/glp/wh_list_intro.htm (and related GLP lists)
  
• 08/02/2005:
  Table for Veterinary Medicine compliance programs is updated to reflect on-line documents and/or information now supplied by the Center for Veterinary Medicine.
• 07/28/2005:
  Revised Debarment List, 07/28/2005 - One person added.
• 07/18/2005:
  Re-numbered existing biologics compliance program 7341.002 “Inspection of Tissue Establishments” to 7341.002A and added new biologics compliance program 7341.002 “Inspection of Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps).”
• 5/31/2005
  Draft revised CPG Sec. 480-200 - Expiration Dating of Unit-Dose Repackaged Drugs (CPG 7132b.11)
  Notice of Availability (HTML) (PDF)
  Draft Guidance (MSWord) (PDF)
• 05/20/2005:
  Revised list to add 1 new member, Restricted List for Clinical Investigators
• 05/19/2005:
  Revised CPG Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG 7124.07)
• 05/17/2005:
  Revised list to add 1 new member, Restricted List for Clinical Investigators
• 05/05/2005:
  Added new biologics compliance program 7345.848 Inspection of Biological Drug Products, and removed four programs that the new program supersedes: 7341.001, 7342.006, 7345.001, and 7345.002.
• 04/25/2005
  Revised CPG 100.700 GWQAP Pre-Award Evaluation - Inadequate Information to Evaluate Prospective Supplier
• 04/25/2005
  Revised CPG 390.300 Assessment of Civil Penalties Against Manufacturers and Importers of Electronic Products
• 04/18/2005:
  Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated April 18, 2005
• 04/13/2005
  Revised CPG Sec. 560.400 Imported Milk and Cream - Federal Import Milk Act CPG 7119.05
• 04/12/2005:
  Revised Debarment List, 04/12/2005 - One person added.
• 04/11/2005:
  Revised list to add 3 new members,
  Restricted List for Clinical Investigators
• 03/23/2005
  Revised list to add one new member; and remove one Application Integrity Policy List
• 03/18/2005
  Revised CPG Sec. 300.500 - Reprocessing of Single Use Devices (CPG 7124.16)
• 03/10/2005
  Revised 8 CPGs to make corrections/minor changes: Sec. 390.100; Sec. 390.400; Sec. 393.100; Sec. 396.300; Sec. 398.100; Sec. 398.325; Sec. 398.425; Sec. 398.700;
• 03/10/2005
  Revoked CPG: Sec. 355.100 - Cellutron Machine
• 03/08/2005
  Revoked 03/08/2005, Compliance Policy Guide, Sec. 160.800 Y2K Computer Compliance
• 03/08/2005:
  Revised list to add 2 new members,
  Restricted List for Clinical Investigators
• 03/04/2005:
  Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
• 02/18/2005:
  Draft revised CPG Sec. 310.210 "Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy (CPG 7124.23)
  FR Notice of Availability   (PDF) 56.8 KB
  Draft Revision (PDF) 382 KB
• 02/01/2005:
  Revised list to add 1 new member,
  Restricted List for Clinical Investigators
• 01/14/2005:
  Revised list to add 1 new member,
  Disqualified/Totally Restricted List for Clinical Investigators