121 STAT. 922
42 USC 282 note.
PUBLIC LAW 110–85—SEPT. 27, 2007
Services shall issue guidance on how the requirements of section 402(j) of the Public Health Service Act, as added by this section, apply to a pediatric postmarket surveillance described in paragraph (1)(A)(ii)(II) of such section 402(j) that is not a clinical trial. (d) PREEMPTION.— (1) IN GENERAL.—Upon the expansion of the registry and results data bank under section 402(j)(3)(D) of the Public Health Service Act, as added by this section, no State or political subdivision of a State may establish or continue in effect any requirement for the registration of clinical trials or for the inclusion of information relating to the results of clinical trials in a database. (2) RULE OF CONSTRUCTION.—The fact of submission of clinical trial information, if submitted in compliance with subsection (j) of section 402 of the Public Health Service Act (as amended by this section), that relates to a use of a drug or device not included in the official labeling of the approved drug or device shall not be construed by the Secretary of Health and Human Services or in any administrative or judicial proceeding, as evidence of a new intended use of the drug or device that is different from the intended use of the drug or device set forth in the official labeling of the drug or device. The availability of clinical trial information through the registry and results data bank under such subsection (j), if submitted in compliance with such subsection, shall not be considered as labeling, adulteration, or misbranding of the drug or device under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
TITLE IX—ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS Subtitle A—Postmarket Studies and Surveillance SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS REGARDING HUMAN DRUGS; RISK EVALUATION AND MITIGATION STRATEGIES.
dkrause on GSDDPC44 with PUBLAW
(a) IN GENERAL.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following subsections: ‘‘(o) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING.— ‘‘(1) IN GENERAL.—A responsible person may not introduce or deliver for introduction into interstate commerce the new drug involved if the person is in violation of a requirement established under paragraph (3) or (4) with respect to the drug. ‘‘(2) DEFINITIONS.—For purposes of this subsection: ‘‘(A) RESPONSIBLE PERSON.—The term ‘responsible person’ means a person who— ‘‘(i) has submitted to the Secretary a covered application that is pending; or
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