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Posted On: 02/23/2021 12:17:38 AM
Post# of 151637
he 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.
FDA new guidelines today:
(P. 11)
Efficacy Endpoints:
In a trial severe or critically ill patients, examples of appropriate endpoints could be
- All-cause mortality at 28 days for hospitalized non critically ill patients. 60 days for critically ill patients.
- Proportion of patients alive and free of respiratory failure at an appropriate time point (e.g. at least 28 days for hospitalized non critically ill patients. 60 days
• 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.
FDA new guidelines today:
(P. 11)
Efficacy Endpoints:
In a trial severe or critically ill patients, examples of appropriate endpoints could be
- All-cause mortality at 28 days for hospitalized non critically ill patients. 60 days for critically ill patients.
- Proportion of patients alive and free of respiratory failure at an appropriate time point (e.g. at least 28 days for hospitalized non critically ill patients. 60 days
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