FDA Has Questions On Transplant Drug

Elizabeth Jones

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FDA Has Questions On Transplant Drug

机译：FDA对移植药物有疑问

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Japanese drugmaker Astellas is evaluating plans for its immunosuppressant FK506 after the FDA issued an approvable letter for the drug's use in preventing organ rejection in kidney transplant patients. The company said it will work with the FDA to resolve issues brought up in the letter as it seeks approval for FK506 (tacrolimus), a once-daily formulation of Prograf.

机译：日本食品制造商阿斯特拉（Astellas）正在评估其免疫抑制剂FK506的计划，此前美国食品药品管理局（FDA）发出了该药物用于预防肾移植患者器官排斥的批准信。该公司表示，它将与FDA合作解决信中提出的问题，因为它正在寻求批准Prograf的每日配方FK506（他克莫司）。

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《Washington Drug Letter》 |2008年第12期|p.6|共1页
作者
Elizabeth Jones;
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正文语种 eng
中图分类生物科学;
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1. Current FDA-Related Drug Information New Drugs Approved by the FDA New Dosage Forms and Indications Approved by the FDA Agents Pending FDA Approval New Drug/Biologies License Applications Filed by Manufacturer Supplemental Actions Filed by Manufacturer Significant Labeling Changes or "Dear Health Professional" Letters Related to Safety [J] . Danial E. Baker Hospital pharmacy. . 2011,第9期

机译：当前与FDA有关的药物信息由FDA批准的新药物新剂型和适应症，由FDA代理商批准的待批FDA批准的新药/生物许可申请，由制造商提出的补充措施，由制造商提出的重要措施，或与“亲爱的健康专业人员”的信件有关安全
2. Current FDA-Related Drug Information New Drugs Approved by the FDA New Dosage Forms and Indications Approved by the FDA Agents Pending FDA Approval New Drug/Biologies License Applications Filed by Manufacturer Significant Labeling Changes or "Dear Health Professional" Letters Related to Safety [J] . Danial E. Baker Hospital pharmacy. . 2011,第8期

机译：当前与FDA有关的药物信息由FDA批准的新药物，由FDA代理批准的新剂型和适应症，待FDA批准的新药物/生物学许可由制造商提交的重要标签变更或与安全相关的“亲爱的健康专业人员”信函
3. Current FDA-Related Drug Information New Drugs Approved by the FDA New Dosage Forms and Indications Approved by the FDA Agents Pending FDA Approval New Drug/Biologies License Applications Filed by Manufacturer Supplemental Applications Filed by Manufacturer Significant Labeling Changes or "Dear Health Professional" Letters Related to Safety [J] . Danial E. Baker Hospital pharmacy. . 2010,第6期

机译：当前与FDA有关的药物信息由FDA批准的新药物，由FDA代理商批准的新剂型和适应症，待FDA批准的制造商提出的新药/生物许可申请，制造商提出的补充申请，重要的标签变更或与“亲爱的健康专业人员”的信件安全
4. Using Machine Learning to Predict the Binding Dissociation of FDA Approved Drugs for Affinity- Based Drug Delivery Applications [C] . Edgardo Rivera-Delgado, Alison Xin, Horst A. von Recum Society for Biomaterials annual meeting and exposition . 2019

机译：使用机器学习预测基于亲和力的药物递送应用的FDA批准药物的结合解离
5. Personalizing Therapy in Transplantation: Focus on Pharmacokinetics, Pharmacodynamics and Pharmacogenomics of Drugs Used in Hematopoeitic Stem Cell and Kidney Transplant. [D] . Sanghavi, Kinjal Jayesh. 2016

机译：个性化移植治疗：专注于造血干细胞和肾脏移植的药物的药代动力学，药效学和药物基因组学。
6. FDA needs more funding NEJM says amid questions about antidiabetes drug [O] . Janice Hopkins Tanne 2007

机译：NEJM表示在有关抗糖尿病药物的疑问中FDA需要更多资金
7. FDA needs more funding, NEJM says, amid questions about antidiabetes drug [O] . Tanne, Janice Hopkins 2007

机译：NEJM表示，在有关抗糖尿病药物的疑问中，FDA需要更多资金
8. Advances in FDAs Safety Program for Marketed Drugs: Establishing Premarket Safety Review and Marketed Drug Safety as Equal Priorities at FDAs Center for Drug Evaluation and Research. [R] . 2012

机译：FDas安全计划在市场营销中的应用：在FDas药物评估和研究中心建立上市前安全审查和上市药物安全作为平等优先事项。

FDA Has Questions On Transplant Drug

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