Page:United States Statutes at Large Volume 111 Part 3.djvu/225

 •%&\J^-' PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2313 SEC. 115. CLINICAL INVESTIGATIONS. (a) CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL. —Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end the following: "If the Secretary determines, based on relevan G science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary may consider such data and evidence to constitute substantial evidence for purposes of the preceding sentence.". (b) WOMEN AND MINORITIES.— Section 505(b)(1) (21 U.S.C. 355(b)(1)) is amended by adding at the end the following: "The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by clause (A).". SEC. 116. MANUFACTURING CHANGES FOR DRUGS. (a) IN GENERAL. —Chapter V, as amended by section 112, is amended by inserting after section 506 the following section: "SEC. 506A. MANUFACTURING CHANGES. 21 USC 356a. "(a) IN GENERAL. —With respect to a drug for which there is in effect an approved application under section 505 or 512 or a license under section 351 of the Public Health Service Act, a change from the manufacturing process approved pursuant to such application or license may be made, and the drug as made with the chsmge may be distributed, if— "(1) the holder of the approved application or license (referred to in this section as a Tiolder') has validated the effects of the change in accordance with subsection (b); and "(2)(A) in the case of a major manufacturing change, the holder has complied with the requirements of subsection (c); or "(B) in the case of a change that is not a major manufacturing change, the holder complies with the applicable requirements of subsection (d). "(b) VALIDATION OF EFFECTS OF CHANGES.— For purposes of subsection (a)(1), a drug made with a manufacturing change (whether a major manufacturing change or otherwise) may be distributed only if, before distribution of the drug as so made, the holder involved validates the effects of the change on the identity, strength, quality, purity, and potency of the drug as the identity, strength, quality, purity, and potency may relate to the safety or effectiveness of the drug. " (c) MAJOR MANUFACTURING CHANGES. — "(1) REQUIREMENT OF SUPPLEMENTAL APPLICATION.—For purposes of subsection (a)(2)(A), a drug made with a major manufacturing change may be distributed only if, before the distribution of the drug as so made, the holder involved submits to the Secretary a supplemental application for such change and the Secretary approves the application. The application shall contain such information as the Secretary determines to be appropriate, and shall include the information developed under subsection (b) by the holder in validating the effects of the change. 39-194O-97-8:QL3Part3

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