; and (5) in section 565A(a)(4)(D) (21 U.S.C. 360bbb–4a(a)(4)(D)), by striking active ingredient (including any ester or salt of the active ingredient) and inserting active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) . 209. Streamlining the transition of biological products Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 ( Public Law 111–148 ) is amended by adding at the end the following: With respect to an application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) with a filing date that is not later than September 23, 2019, the Secretary shall continue to review and approve such application under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), even if such review and approval process continues after March 23, 2020. Effective on the later of March 23, 2020, or the date of approval of such application under such section 505, such approved application shall be deemed to be a license for the biological product under section 351 of the Public Health Service Act. . 210. Orphan drug clarification Section 527(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc(c) ) is amended by adding at the end the following: (3) Applicability This subsection applies to any drug designated under section 526 that was approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act after the date of enactment of the FDA Reauthorization Act of 2017, regardless of the date of on which such drug was designated under section 526. . 211. Prompt approval of drugs related to safety information Section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) is amended by adding at the end the following: (z) Prompt Approval of Drugs When safety information Is Added to Labeling (1) General rule A drug for which an application has been submitted or approved under subsection (b)(2) or (j)