Sec. 209. Streamlining the transition of biological products
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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.
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- Pub. L. 111-148
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