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Zdrowie i gospodarka · 2/24/2022

Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising From the COVID-19 Pandemic; Guidance for Industry; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic." The COVID-19 pandemic has resulted in a significant reduction in the supply of nonhuman primates (NHPs) available for conducting toxicology studies for new pharmaceuticals. This has the potential to significantly delay the development of new medications for the treatment of diseases currently without effective treatment options. This guidance provides FDA's recommendations to industry to help mitigate the NHP supply issue by reducing the demand for NHPs during the COVID-19 pandemic. Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →