FDA updates guidance on investigational use of convalescent plasma for COVID-19

Regulatory NewsRegulatory News | 04 May 2020 |  By 

Credit: CDC/ C.S. Goldsmith and A. Tamin

The US Food and Drug Administration (FDA) on Friday updated its recommendations for clinical investigators looking to use convalescent plasma to treat patients with coronavirus disease (COVID-19).
“Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19,” FDA writes, noting that convalescent plasma has been studied to treat other respiratory viruses, including SARS and MERS.
FDA says the updated guidance provides clarifications for submitting investigational new drug (IND) applications, expanded access INDs or single-patient emergency INDs. (RELATED: FDA, EC offer guidance on COVID-19 convalescent plasma, Regulatory Focus 9 April 2020).
The updated guidance also eases donor qualification requirements by shortening the timeframe after resolution of symptoms from 28 to 14 days and lifting a requirement for donors to have a negative diagnostic test result in order to qualify.
FDA also clarifies its recommendations for sample retention as part of its donor eligibility criteria in situations where it is not possible to measure neutralizing antibody titers. While FDA recommends storing retention samples from donors in larger INDs to determine antibody titers later on, it does not recommend doing so for single-patient emergency INDs.


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Tags: coronavirus, US

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