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ICCVAM Biennial Report 2020-2021

Biennial Progress Report 2020-2021 Interagency Coordinating Committee on the Validation of Alternative Methods
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FDA Partnership to Apply Lung Chips to Safety Evaluation of COVID-19 Vaccines and Therapies

In October 2020, FDA entered into a Cooperative Research and Development Agreement with Emulate, Inc. to enable multiple studies using Emulate’s Organ-Chips across FDA offices in priority research areas. Organ-Chips are in vitro systems that recreate the natural physiology of specific human tissues and organs. Some projects will evaluate COVID-19 vaccines or investigate human immune response against SARS-CoV-2, the virus that causes COVID-19. Under the agreement, FDA will use a range of Organ-Chips to study the safety, efficacy, and mechanisms of action of drugs regulated by the FDA. This new agreement follows the successful completion of the first Emulate Cooperative Research and Development Agreement with the FDA initiated in 2017 that focused on toxicity studies using Emulate's Liver-Chip.

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