Section 801 of FDAAA does not provide for a waiver of the new requirement to include
the new statement in the informed consent documents and process for applicable clinical
trials. FDA’s regulations require informed consent for participation in FDA-regulated
clinical investigations except under limited circumstances as described in 21 CFR § 50.23
(involving certain life-threatening situations, military operations, or public health
emergencies) and 21 CFR § 50.24 (involving emergency research).
