• United States Code
    • TITLE 21 - FOOD AND DRUGS
      • CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
        • SUBCHAPTER V - DRUGS AND DEVICES
          • PART D - DISSEMINATION OF TREATMENT INFORMATION
            • Section 360aaa-1
              • Section 360aaa-1. Information authorized to be disseminated


(a) Authorized information A manufacturer may disseminate information under section 360aaa of this title on a new use only if the information - (1) is in the form of an unabridged - (A) reprint or copy of an article, peer-reviewed by experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or device involved, which was published in a scientific or medical journal (as defined in section 360aaa-5(5) of this title), which is about a clinical investigation with respect to the drug or device, and which would be considered to be scientifically sound by such experts; or (B) reference publication, described in subsection (b) of this section, that includes information about a clinical investigation with respect to the drug or device that would be considered to be scientifically sound by experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or device that is the subject of such a clinical investigation; and (2) is not false or misleading and would not pose a significant risk to the public health. (b) Reference publication A reference publication referred to in subsection (a)(1)(B) of this section is a publication that - (1) has not been written, edited, excerpted, or published specifically for, or at the request of, a manufacturer of a drug or device; (2) has not been edited or significantly influenced by such a manufacturer; (3) is not solely distributed through such a manufacturer but is generally available in bookstores or other distribution channels where medical textbooks are sold; (4) does not focus on any particular drug or device of a manufacturer that disseminates information under section 360aaa of this title and does not have a primary focus on new uses of drugs or devices that are marketed or under investigation by a manufacturer supporting the dissemination of information; and (5) presents materials that are not false or misleading.





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