U.S. Food & Drug Administration (FDA) CBER's Guidances Update

• Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis (PDF - 188KB)


• Posted: 2/26/2013


• http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTMwMjI2LjE1OTk3MjcxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDEzMDIyNi4xNTk5NzI3MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MDQ0NDgzJmVtYWlsaWQ9Y2VyYXNhbGUzMTRAZ21haWwuY29tJnVzZXJpZD1jZXJhc2FsZTMxNEBnbWFpbC5jb20mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&100&&&http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM340993.pdf?source=govdelivery


• Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma (PDF - 95KB)


• Posted: 2/26/2013


• http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/UCM341088.pdf?source=govdelivery