2006 Revisions and Updates

• 11/21/2006:
  Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated November 21, 2006
• 11/09/2006:
  Compliance Program Guidance Manual, Program 7342.007 "Examination of Blood and Blood Components Offered for Import" is withdrawn and replaced by Program 7342.007 "Imported Human Cells, Tissues, and Cellular and Tissue-based Products". The withdrawn Program was never electronically available but the replacement Program is now on-line.
• 11/02/2006:
  CPG Manual Revised; "Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16)", updated generally, and specifically with respect to device registration regulations.
• 10/23/2006:
  Revised list to add 1 new member, Disqualified/Totally Restricted List for Clinical Investigators
• 10/17/2006:
  Revised Debarment List, 10/17/2006 - One person added.
• 10/11/2006:
  Revised list to add 1 new member, Disqualified/Totally Restricted List for Clinical Investigators
• 08/24/2006:
  New Guidance That Replaces CPG Sec 110-300, Compliance Policy Guide Guidance for FDA Staff Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
• 06/20/2006:
  Compliance Program Guidance Manual: Program 7371.001, "Animal Drug Manufacturing Inspections" revised; program formerly titled "Drug Process and New Animal Drug Inspections."
• 08/04/2006:
  Clinical Investigator Agrees to Restrictions. See Restricted List for Clinical Investigators for the details.
• 07/26/2006:
  Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated July 26, 2006
• 07/17/2006
  Revised list to add 1 new member, Restricted List for Clinical Investigators
• 06/20/2006
  New Guidance which Replaces CPG Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs (CPG 7132c.02)
• 06/20/2006
  DRAFT COMPLIANCE POLICY GUIDE 160.900 Prescription Drug Marketing Act – Pedigree Requirements under 21 CFR Part 203
• 06/19/2006
  March 2006 edition of the Regulatory Procedures Manual (RPM) published.
• 06/15/2006:
  Compliance Program Guidance Manual: Program 7382.845, "Inspection of Medical Device Manufacturers " revised.
• 05/26/2006:
  Draft Compliance Policy Guide:
  Guidance Levels for 3-MCPD (3- chloro-1,2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces
  Revised list to add 1 new member, Restricted List for Clinical Investigators
• 05/16/2006:
  Revised Medical Device Model Press Release
• 05/09/2006:
  Revised list to change status to Active - Exygen Research, State College, PA
• 04/07/2006:
  Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated April 7, 2006
• 03/08/2006:
  Revised list to add 1 new member, Restricted List for Clinical Investigators
• 02/09/2006:
  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
• 01/19/2006:
  Change in classification (Class) - Pine Acres Research Facility, Norton, MA
• 01/11/2006:
  Updated list to remove restriction for 1 member. Restricted List for Clinical Investigators