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U.S. Code, Title 21, Food and Drugs
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General SummaryThe U.S. Code is a consolidation and codification by subject matter of the general and permanent laws of the United States. While every effort has been made to ensure that this reproduction of the Code is accurate, those using it for legal purposes should verify their results against the printed version of the Code available through the Government Printing Office.
§ 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.
(June 25, 1938, ch. 675, § 552, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2358.)
Termination of Section
For termination of section by section 401(e) of Pub. L. 105–115, see Effective and Termination Dates note set out under section 360aaa of this title.
Section Referred to in Other Sections
This section is referred to in section 360aaa of this title.
Contents:
Chicago: "U.S. Congress, Office of the Law Revision Counsel", "§ 360aaa– 1. Information Authorized to Be Disseminated," U.S. Code, Title 21, Food and Drugs in U.S. Code, Title 21, Food and Drugs (Washington, D.C.: Government Printing Office, 2002), Original Sources, accessed October 10, 2024, http://www.originalsources.com/Document.aspx?DocID=DM3RHIGQBI6F8NH.
MLA: "U.S. Congress, Office of the Law Revision Counsel". "§ 360aaa– 1. Information Authorized to Be Disseminated." U.S. Code, Title 21, Food and Drugs, in U.S. Code, Title 21, Food and Drugs, Washington, D.C., Government Printing Office, 2002, Original Sources. 10 Oct. 2024. http://www.originalsources.com/Document.aspx?DocID=DM3RHIGQBI6F8NH.
Harvard: "U.S. Congress, Office of the Law Revision Counsel", '§ 360aaa– 1. Information Authorized to Be Disseminated' in U.S. Code, Title 21, Food and Drugs. cited in 2002, U.S. Code, Title 21, Food and Drugs, Government Printing Office, Washington, D.C.. Original Sources, retrieved 10 October 2024, from http://www.originalsources.com/Document.aspx?DocID=DM3RHIGQBI6F8NH.
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