FDA批准抗凝血新药Pradaxa |
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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 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 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 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 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 Significant Labeling Changes or "Dear Health Professional" Letters Related to Safety [J] . Danial E. Baker Hospital pharmacy. . 2010,第4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 4. The travail involved in getting FDA approval . . . an overview on what it took to get FDA approval of a medical device with computer technology (A recent experience) [C] . Paul A., Institute of Electric and Electronic Engineer Symposium on the Engineering of Computer-Based Medical Systems . 1988机译：获得FDA批准所涉及的痕迹。 。 。概述通过计算机技术获得FDA批准的FDA批准（最近的经验） 5. Evidence Supporting FDA Approval and CMS National Coverage Determinations for Novel Medical Products, 2005 through 2016: A Cross-Sectional Study [D] . Roginiel, Aliya C. 2019机译：证据支持FDA批准和CMS全国新型医疗产品的覆盖范围，2005年至2016年：横断面研究 6. FDA Guidance and New Drug Approvals [O] . Scot Walker 2018机译：FDA指南和新药批准 7. FDA Town Hall—New Drug Approvals in Gastrointestinal Disease (2018–2019) [O] . M. Scott Harris, Colin W. Howden, Juli Tomaino, 2020机译：FDA市政厅 - 胃肠疾病的新药批准（2018-2019） 8. Guidance for FDA Staff and Industry: Marketed Unapproved Drugs. Compliance Policy Guide. Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs (September 19, 2011) [R] . 2011机译：FDa工作人员和行业指南：未经批准的未经批准的药物。合规政策指南。秒。 440.100未经批准的NDa或aNDa上市的新药（2011年9月19日） |
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