Zdrowie i gospodarka · 20/12/2019

FDA Releases Final Guidance for Dried Plasma Product Development

The US Food and Drug Administration (FDA) has released a final guidance document titled 'Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry,' which provides recommendations for manufacturers and sponsors to develop safe and effective dried plasma products for transfusion in the US. The guidance covers various aspects of dried plasma product development, including input plasma sources, manufacturing quality, and clinical studies.