On September 29, 2010 FDA published a Final Rule revising the requirements for safety reporting for INDs and other BE/BA studies. At the same time FDA issued an accompanying draft guidance to assist in interpreting the new rule. The Final Rule, revising 21 CFR §§ 312.32, 312.64 and 320.31, becomes effective March 28, 2011.
The change to the IND safety reporting (primarily in 21 CFR § 312.32) is actually somewhat of an attempt by FDA to curb over reporting, especially, for example, single instances which have little or no likelihood of a connection with the test drug. The bulk of the changes come via changes in the definitions of terms such as serious suspected adverse reactions and attempts at clarifying determination of “reasonable possibility”. Sponsors, Investigators and CROs already involved in reporting adverse reactions under an IND may find their reporting burden somewhat reduced, though the actual impact will not be clear for some time.
The part that may well catch some folks napping, however, is the revision to 21 CFR § 320.31, specifically the addition of 21 CFR 320.31(d)(3). For the first time, this new section requires those conducting BE/BA studies who are exempt from filing and meeting the requirements of an IND (via the conditions for exemption laid out in 21 CFR § 320.31) to report “…any serious adverse event, as defined in 21 CFR § 312.32(a).” Previously, BE/BA studies exempt from the requirement of filing an IND were also exempt from all IND requirements, including safety reporting.