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H.Res. 876: Expressing the sense that the process behind Operation Warp Speed should be integrated within operations at the Food and Drug Administration.


The text of the resolution below is as of Jan 19, 2022 (Introduced).


IV

117th CONGRESS

2d Session

H. RES. 876

IN THE HOUSE OF REPRESENTATIVES

January 19, 2022

submitted the following resolution; which was referred to the Committee on Energy and Commerce

RESOLUTION

Expressing the sense that the process behind Operation Warp Speed should be integrated within operations at the Food and Drug Administration.

That it is the sense of Congress that the Commissioner of Food and Drugs should—

(1)

to the extent scientifically and legally possible, integrate the process behind Operation Warp Speed into operations at the Food and Drug Administration;

(2)

issue guidance identifying ways that drug and biological product innovation and development can be accelerated through clinical trials and the approval and licensure processes;

(3)

for purposes of accelerating the approval of new drugs and biological products, cross-reference applicable safety and scientific data from approved drugs and licensed biological products; and

(4)

collect interim data that would allow for parallel assessments of the safety and effectiveness of multiple drugs and biological products and the parallel approval or licensure of multiple drugs and biological products, including through the conduct of concurrent clinical trials.