; (B) a statement identifying contradictory evidence; and (C) such other information as may be required by regulation. (c) Competent and reliable scientific evidence In this section, the term competent and reliable scientific evidence means evidence established through scientific methods that are widely accepted by experts in the relevant field and followed pursuant to a clear and well-described protocol, as scientifically appropriate. Evidence may constitute competent and reliable scientific evidence within the meaning of this section— (1) regardless of whether it is supported by 2 adequate and well-controlled clinical studies; and (2) may include— (A) information derived from clinical trials, observational studies, clinical studies or bench tests that describe performance, database reviews, registries, patient utilization projections, and modeling techniques, and the data, inputs, and components of such information; (B) information about the effects of a drug or device in subgroups defined by demographic or other variables, including groups defined by race, sex, risk factors, or other variables, such as genomic features or disease severity; (C) information related to the emergency use authorization, as applicable; and (D) information relating to the safety, effectiveness, or benefit of a use or treatment that is authorized under section 564 for a drug or device, including information regarding— (i) health outcomes, patient or caregiver experience, or other quality metrics