This post was written by Paul Sheives. FDA has issued a final rule and a draft guidance entitled “Safety Reporting Requirements for INDs and BA/BE Studies,” which seek to clarify what safety information for investigational drugs must be reported to FDA, and the timing requirements for such reports. The final rule requires the rapid submission of certain types of information not previously required on an expedited basis, such as findings from clinical or epidemiological studies that suggest a significant risk or serious, or suspected adverse reactions that occur more frequently than anticipated. The final rule also affects the reporting of information to institutional review boards (IRBs). The scope of the final rule is extensive, and also addresses topics such as requirements relating to follow-up for reports, study unbinding (i.e., when to unblind and report), and the reporting requirements for bioavailability and bioequivalence studies. FDA is accepting written comments on the companion draft guidance until December 28, 2010.