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Regulatory Affairs North America

Committee Meeting Summaries

January 2008
February 2008
March 2008
April 2008
May 2008
June 2008
July 2008
August 2008
September 2008
October 2008

Helpful Links

FDA - CBER                                  Code of Federal Regulations
FDA Forms                                    Federal Register
FDA Guidance Documents           ICH
FDA Liaison Meetings                  ISBT
US Pharmacopeia                         OBA
CLIA                                              CTEP
Canadian Regulations

 

Additional Regulatory Documents and Links can be found on the Lab Practices page.

FDA Alerted of Bovine Brain Material in Collagenase Enzymes

Click here for information.

Cord Blood Transplantation Study
Cord Blood Bank Standard Operating Procedures