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Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem—Are We Ready for a Revolution?

机译：医药产品监管提交的数字创新，审查和批准，创建动态监管生态系统 - 我们为革命准备了吗？

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Judith C. Macdonald; David C. Isom; Daniel D. Evans; Katy J. Page;
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1. Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem—Are We Ready for a Revolution? [J] . Judith C. Macdonald, David C. Isom, Daniel D. Evans, Frontiers in Medicine . 2021,第a期

机译：医药产品监管提交的数字创新，审查和批准，创建动态监管生态系统 - 我们为革命准备了吗？
2. A review of radiation countermeasures focusing on injury-specific medicinals and regulatory approval status: part Ill. Countermeasures under early stages of development along with 'standard of care' medicinal and procedures not requiring regulatory approval for use [J] . Singh Vijay K., Hanlon Briana K., Santiago Paola T., International Journal of Radiation Biology: Covering the Physical, Chemical, Biological, and Medical Effects of Ionizing and Non-ionizing Radiations . 2017,第9期

机译：对伤害特定药物和监管批准状态的辐射对策述评：部分生病问题。初期发展的对策以及“护理标准”药用和程序不需要监管批准
3. Forward for two review articles authored by ISCT's North American Legal & Regulatory Affairs Committee on the regulatory framework for cellular & gene therapy product approval in the US and Canada [J] . Phinney Donald G. Cytotherapy . 2019,第7期

机译：两项审查由ISCT北美法律和监管事务委员会批发的两项审查文章，关于美国和加拿大的细胞和基因治疗产品批准监管框架监管框架
4. Equipment Innovation In Medicine And Rehabilitation: From Idea To Market Place What Approvals Will You Need - Regulatory Affairs [C] . Hartley, J. Equipment Innovation in Medicine and Rehabilitation: From Idea to the Market Place, IEE Colloquium on . 1988

机译：医学和康复领域的设备创新：从构思到市场，您需要什么批准-法规事务
5. Evaluating the regulatory review and approval process for major projects: A case study of the Mackenzie Gas Project. [D] . Wozniak, Kelly. 2007

机译：评估重大项目的监管审查和批准过程：以Mackenzie天然气项目为例。
6. Digital Innovation in Medicinal Product Regulatory Submission Review and Approvals to Create a Dynamic Regulatory Ecosystem—Are We Ready for a Revolution? [O] . Judith C. Macdonald, David C. Isom, Daniel D. Evans, 2021

机译：医药产品监管提交的数字创新审查和批准创建动态监管生态系统 - 我们为革命准备了吗？
7. To the question of experimental legal regime for creating digital innovations (regulatory sandboxes) [O] . Elizaveta Gromova 2019

机译：建立数字创新的实验法律制度问题（监管沙箱）
8. Regulatory Impact Analysis for the National Primary Drinking Water Regulations:Disinfectants/Disinfection By-Products Rule. Appendix Volume 1: Disinfection By-Products Regulatory Analysis Model (DBP-RAM). Part 2: Critical Reviews and Refinements Made to S [R] . Rourke, B., Regli, S. 1994

机译：国家初级饮用水法规的监管影响分析：消毒剂/消毒副产品规则。附录第1卷：消毒副产品法规分析模型（DBp-Ram）。第2部分：对s的批评性评论和改进

Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem—Are We Ready for a Revolution?

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