; or (B) scientific exchange as described in subsection (b). (b) Scientific exchange (1) In general For purposes of this Act, including sections 301(d), 502(f)(1), 505, 510(k), and 515 and for purposes of section 351 of the Public Health Service Act, the scientific exchange of information about a drug, biological product, or device, as described in paragraph (2), shall not constitute labeling, advertising, or evidence of a new intended use. (2) Requirements for scientific exchange A communication by a manufacturer or sponsor, or a person acting on behalf of a manufacturer or sponsor, about the manufacturer’s or sponsor’s drug, biological product, or device, or use of such drug, biological product, or device, that has not been approved for marketing under section 505, 510, or 515 of this Act or section 351 of the Public Health Service Act, about a device or use of such device that has not been approved or cleared for marketing under section 510 or 515 of this Act, or about information that is not included in the drug, biological product, or device labeling, constitutes scientific exchange when— (A) the communication is supported by scientifically appropriate and statistically sound data, studies, or analyses; (B) the communication includes a conspicuous and prominent statement that the drug, biological product, or device, or use of such drug, biological product, or device, that is the subject of the communication, has not been approved for marketing under section 505, 510, or 515 of this Act or section 351 of the Public Health Service Act, or that such communication includes information that is not contained in the drug, biological product, or device labeling, as applicable