DRUG SURVEILLANCE.

SEC. 3075. DRUG SURVEILLANCE. (a) New drugs.—Section 505(k)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by section 3102, is further amended— (1) in subparagraph (A), by striking “, bi-weekly screening” and inserting “screenings”; (2) in subparagraph (B), as redesignated by section 3102(1)(C), by striking the period at the end and inserting “; and”; and (3) by adding at the end the following: “(C) make available on the Internet website of the Food and Drug Administration— “(i) 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 “(ii) criteria for public posting of adverse event signals.” . (b) FAERS Revision.—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;”. (c) Risk evaluation and mitigation strategies.—Section 505-1(f)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f)(5)) is amended— (1) in the matter preceding subparagraph (A), by inserting “or other advisory committee” after “(or successor committee)”; and (2) in subparagraph (B), by striking “at least annually,” and inserting “periodically”.