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USFDA Guidance: Updates on Blood Donor Eligibility, Donation Suitability, and Blood Pressure and Pulse Requirements
The US Food and Drug Administration (FDA) has issued two compliance policy guidances addressing requirements for blood establishments that collect blood and blood components, including Source Plasma. The guidance on Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements and the guidance on Blood Pressure and Pulse Donor Eligibility Requirements describe circumstances where FDA does not intend to take regulatory action
Sharan Murugan
5 hours ago3 min read
UsFDA Guidance: Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to an Ebola Disease Outbreak
Maintaining the safety of the blood supply is a critical public health priority, particularly during outbreaks of emerging infectious diseases. Ebola disease, caused by viruses of the Orthoebolavirus genus, is associated with severe illness and can be transmitted through direct contact with infected body fluids. Although transfusion-transmitted Ebola disease has not been widely documented, the potential risk of transmission through blood and blood components requires appropri
Sharan Murugan
Jul 23 min read