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Re: None

Monday, 02/22/2021 1:27:52 PM

Monday, February 22, 2021 1:27:52 PM

Post# of 44690
The FDA just published updated guidance for Therapeutics. They specifically mention—

• In their endpoint definition, sponsors should address the occurrence of relapses to ensure adequate assessment of the durability of response

Link: https://www.fda.gov/media/137926/download
FDA has also revised a second guidance covering drugs and biological products more broadly for COVID-19, COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.