FDA Modernization Act of 2021
This bill allows an applicant for market approval for a new drug to use methods other than animal testing to establish the drug's safety and effectiveness. Under this bill, these alternative methods may include cell-based assays, organ chips and microphysiological systems, computer modeling, and other human biology-based test methods.
To amend the Federal Food, Drug, and Cosmetic Act to allow 
manufacturers and sponsors of a drug to use alternative testing methods 
  to animal testing to investigate the safety and effectiveness of a 
                     drug, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA Modernization Act of 2021''.

SEC. 2. NEW APPROACH METHODOLOGIES.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended--
            (1) in subsection (b)(5)(B)(i)(II), by striking ``animal'' 
        and inserting ``nonclinical tests or studies'';
            (2) in subsection (i)--
                    (A) in paragraph (1)(A), by striking ``preclinical 
                tests (including tests on animals)'' and inserting 
                ``nonclinical tests''; and
                    (B) in paragraph (2)(B), by striking ``animal'' and 
                inserting ``nonclinical tests or studies''; and
            (3) after subsection (y), by inserting the following:
    ``(z) Nonclinical Test or Study Defined.--For purposes of this 
section, the term `nonclinical test or study' means a test or study 
conducted in vitro, in silico, in chemico, or in vivo that occurs 
before or during the clinical trial phase of the investigation of the 
safety and effectiveness of a drug, and may include the following:
            ``(1) Cell-based assays.
            ``(2) Organ chips and microphysiological systems.
            ``(3) Computer models.
            ``(4) Other non-animal or human biology-based test methods.
            ``(5) Animal tests.''.
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FDA Modernization Act of 2021
A bill to amend the Federal Food, Drug, and Cosmetic Act to allow manufacturers and sponsors of a drug to use alternative testing methods to animal testing to investigate the safety and effectiveness of a drug, and for other purposes.
FDA Modernization Act of 2021
Sen. Paul, Rand