Two new regulations were created: 

·         Institutional Review Boards (IRBs) reviewing FDA regulated research in the U.S. are required to register with FDA in 2009.

·        The standards have been updated for acceptance of data from foreign clinical trials not conducted under IND.  (A friend of mine who teaches at the University says that it better to use the word “international” versus “foreign” ……but no one has asked for my opinion.) 

Five new guidance documents were written:

·         Final Guidance – “Adverse Event Reporting to IRBs – Improving Human Subject Protection”

·         Final Guidance – “Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials”

·         Draft Guidance – “Humanitarian Device Exemption (HDE) Regulation: Questions and Answers”

·         Draft Guidance – “Frequently Asked Questions – Statement of Investigator (Form FDA 1572)”

·         Final Guidance – “Computerized Systems Used in Clinical Trials”

According to FDA there have been improvements in their internal procedures, a new public / private partnership with Duke University has been created to increase the quality / efficiency of clinical trials and additional guidance documents are on the list to be written or finalized.

Metrics were posted documenting the number and outcomes of BIMO inspections conducted last year.  A total of 1126 inspections were conducted in 2008.  This reflects inspections of clinical investigators, IRBs, non-clinical laboratories, human drug in vivo bioequivalence studies, sponsors, contract research organizations and monitors.  The majority of inspections conducted were for clinical investigators.  The highest percentage of inspections identifying significant problems was for inspections of sponsors, contract research organizations and monitors. 

Can we expect to see this summary every year from FDA?