The article discusses the draft guidance that was released by the U.S. Food and Drug Administration (FDA) for blood establishments on how to assess blood donor suitability, donor referral and blood product management during Ebola virus outbreaks....
Gottlieb said that the agency will continue advancing policy work in certain areas, such as developing guidance, though he noted that the funding lapse will prevent the agency from working on other guidances. Gottlieb clarified that FDA will be able to process certain submissions for generic drugs...
• Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Draft Guidance for Industry 指南题目:开发用于使用血沉棕黄层法制造血液成分的...
This guidance excludes all vaccines, whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), and gene therapy APIs. However, it does include APIs that are produced using blood or plasma as raw materials. Note that cell substrates (mammalian, plant, insect or mi...
美国联邦法规 21 CFR 606 “血液及血液成分良好操作规 范”,针对血液与血液制品的制造、成品控制、实验室控制等做出规范,并附加 人体血液和血液制品的标准,包括了全血(Whole Blood)、红血球(Red Blood Cells)、 血小板(Platelets)、血浆(Plasma)、冷沉淀剂(Cryoprecipitate)、原料血浆(Source Plasma)、白蛋白(人类)...
This guidance excludes all vaccines, whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), and gene therapy APIs. However, it does include APIs that are produced using blood or plasma as raw materials. Note that cell substrates (mammalian, plant, insect or ...
Thisguidanceexcludesallvaccines,wholecells,wholebloodandplasma,bloodandplasmaderivatives(plasmafractionation),andgenetherapyAPIs.However,itdoesincludeAPIsthatareproducedusingbloodorplasmaasrawmaterials.Notethatcellsubstrates(mammalian,plant,insectormicrobialcells,tissueoranimalsourcesincludingtransgenicanimals)andearly...
The FDA first issued guidance on Feb. 16 recommending that only areas with active Zika virus transmission screen donated whole blood and blood components for the virus, or halt blood collection. The first local or non-travel related transmission of Zika virus in the U.S. by mosquitoes was rep...
The information in this guidance applies to bioanalytical procedures such as chromatographic assays (CCs) and ligand binding assays (LBAs) that quantitatively determine the levels of drugs, their metabolites, therapeutic proteins, and biomarkers in biological matrices such as blood, serum, plasma, urine...
Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels: Guidance for Industry 2024年4月30日，FDA发布了一份题为“统一血液和血液成分容器标签标准的认可和使用”的指南，并取代了2014年6月发布的同名指南。FDA CBER承认血液和血液成分生产商，在遵守美国法律和法规的前提下，...