The FDA has now approved new regulations pertaining to the registration of Institutional Review Boards.

SUMMARY: The Food and Drug Administration (FDA, we) is issuing a final rule to require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). The
registration information includes contact information (such as addresses and telephone numbers), the number of active protocols involving FDA regulated products reviewed during the preceding 12 months, and a description
of the types of FDA-regulated products involved in the protocols reviewed. The IRB registration requirements will make it easier for FDA to inspect IRBs and to convey information to IRBs.

DATES: This rule is effective July 14,
2009. This effective date is necessary to allow refinement of the electronic registration system so that it corresponds to this final rule. All IRBs must comply with the initial registration requirement and, if necessary, make
required revisions to their registrations by September 14, 2009.

For more information on this please contact mdi at info@mdiconsultants.com.