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Home Guideline News

FDA issues guidance on remote evaluation of manufacturing facility during the COVID-19

PRN by PRN
April 15, 2021
in Guideline News, US FDA
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FDA issues guidance on remote evaluation of manufacturing facility during the COVID-19
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FDA is issuing this guidance to describe how we will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring (BIMO) program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the duration of the COVID-19 public health emergency.

Guidance can be found at below link

https://www.fda.gov/media/147582/download

 

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