505G. Safety and effectiveness of drugs with respect to racial and ethnic background (a) Preapproval studies If there is evidence that there may be a disparity on the basis of racial or ethnic background or other demographic characteristics (such as age, sex, gender) as to the safety or effectiveness of a drug or biological product or if such product addresses a disease that disproportionately impacts certain racial or ethnic groups or other demographic characteristics (such as age, sex, gender), then— (1) (A) in the case of a drug, the investigations required under section 505(b)(1)(A) shall include adequate and well-controlled investigations of the disparity