Posted October 1, 20195 yr comment_78491 Hi Blood Bankers, Rumor has it that the FDA has issued Final Guidance for the Psoralen pathogen inactivated platelets. Has anyone seen a copy? Maryann
October 1, 20195 yr comment_78492 As far as I know, FDA currently has a draft guidance for pathogen reduced platelets. FDA recently came out with the final regarding bacterial risk and platelets. You can search for FDA guidance's any time. Copy this link https://www.fda.gov/regulatory-information/search-fda-guidance-documents
October 2, 20195 yr comment_78498 The final came out on Sept 20th, no longer a draft. We have 18mths to implement. Bacterial-Risk-Control-Strategies-for-Blood-Collection-Establishments_09-2019.pdf
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