Zdrowie i gospodarka · 22/07/2024

FDA Releases Guidance for COVID-19 Convalescent Plasma Manufacturing

The FDA has released a final guidance for the industry on submitting a Biologics License Application (BLA) for COVID-19 convalescent plasma intended for transfusion in immunosuppressed patients, and for investigational new drug applications (INDs) for investigational COVID-19 convalescent plasma.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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