The Food and Drug Administration (FDA) has issued a final rule that amends its "regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND)."Titled “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,” the new rule is effective March 28, 2011. When it issued the rule, the agency also published a draft guidance document to assist “sponsors and investigators” required to comply with the rule. FDA requests comments on the guidance by December 28, 2010.
Among other matters, the rule now provides definitions for “adverse event,” “life-threatening adverse event,” “serious adverse event,” “suspected adverse event,” and “unexpected adverse event.” The rule also clarifies how and when to submit IND safety reports to FDA, clarifies “the sources of information that sponsors must review for safety surveillance and reporting purposes,” and makes “bioavailability and bioequivalence studies subject to IND safety reporting requirements.” See Federal Register, September 29, 2010.