Sec. 3075. Drug surveillance
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/bill/114/hr/34/enr/section-3075·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 505(k)(5) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(k)(5) ), as amended by section 2074, is further amended— in subparagraph (A), by striking , bi-weekly screening and inserting screenings ; in subparagraph (B), as redesignated by section 2074(1)(C), by striking the period at the end and inserting ; and ; and by adding at the end the following: make available on the Internet website of the Food and Drug Administration— guidelines, developed with input from experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, that detail best practices for drug safety surveillance using the Adverse Event Reporting System; and criteria for public posting of adverse event signals. .
Section 505(r)(2)(D) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(r)(2)(D) ) is amended by striking , by 18 months and all that follows through the semicolon at the end of the subparagraph and inserting and making publicly available on the Internet website established under paragraph
(1)best practices for drug safety surveillance activities for drugs approved under this section or section 351 of the Public Health Service Act; . Section 505–1(f)(5) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(f)(5) ) is amended— in the matter preceding subparagraph (A), by inserting or other advisory committee after (or successor committee) ; and in subparagraph (B), by striking at least annually, and inserting periodically .
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U.S. Code
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- 21 USC 355–1(f)(5)
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