Background and Aims: On November 24, 2009, Huu S. TIEU and Golden Sunrise Pharmaceutical, Inc. (Golden Sunrise) applied for the Technology and Innovation to be reviewed and evaluated by the U.S. Food and Drug Administ...Background and Aims: On November 24, 2009, Huu S. TIEU and Golden Sunrise Pharmaceutical, Inc. (Golden Sunrise) applied for the Technology and Innovation to be reviewed and evaluated by the U.S. Food and Drug Administration (FDA). In the review and evaluation, it was requested by Golden Sunrise designated the new indications for this application under Serious or Life-threatening conditions or diseases. Discussions followed with the FDA, Huu S. TIEU, and Golden Sunrise for FDA approval on new products and new indications on existing new Medical Technology and Innovation. It was agreed in Year-2015 that the FDA would take the request for new indications to the United States Congress to establish into FDA regulation and law. At that time the following was the FDA Guidance—“Emergency Use of a Test Article” is exempt from prior Institutional Review Board or Advisory Committee evaluation and approval, provided that such emergency use is reported to the Institutional Review Board within five working days after use. Expedited Institutional Review Board or Advisory Committee approval is not permitted in emergency use. There has been no funding to the authors for the writing or publication of this article. Methods: It was requested by Huu S. TIEU and Golden Sunrise in documents given to the FDA to have Serious or Life-threatening conditions or diseases indication be recognized by law. On August 08, 2015, the FDA responding to this request took the documentation produced by Golden Sunrise to the United States Congress on behalf of Golden Sunrise and Huu S. TIEU. This article encompasses the FDA regulatory method as well as the discussion and results of the establishment of the FDA and the 21<sup>st</sup> Century Cures Act. Results: On December 13, 2016, H.R.34—114<sup>th</sup> United States Congress (2015-2016) 21<sup>st</sup> Century CURES Act was signed into law by President Barack H. Obama which included the Serious or Life-threatening indication to be written into the CURES Act. In summary, the 21<sup>st</sup> Century Cures Act is a landmark piece of legislation that enjoyed broad bipartisan support in United States Congress. The main goals of the Act are impactful and should transform future cancer, neurologic, and precision medicine or drug research as well as aid individuals with mental health is intended to facilitate the prompt approval of new agents and devices, clinicians should be aware of the types of data behind an approval and take this into consideration when developing illnesses and opioid dependence. However, some of the wording within the CURES Act regarding the drug and device approval process may bring pause to health care providers including pharmacists. Although this wording and implementing care plans and counseling patients. The 21<sup>st</sup> Century Cures Act was incorporated into laws and regulations by the FDA under § 3072 of the Act grants the Commissioner of Food and Drugs the authority to appoint and set the annual rate of pay for outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products.展开更多
In order to promote China to take part in the activities of international standardization and improve the standardization level of China, Mr. Oliver Smoot, President of ISO, made a public speech on international stand...In order to promote China to take part in the activities of international standardization and improve the standardization level of China, Mr. Oliver Smoot, President of ISO, made a public speech on international standardization of the global economy at the invitation of SAC (Standardization Administration of China) on Nov. 1st.展开更多
Scientific and technology are the first productivity. They are the revolutionary power of accelerating the civilization progress of the human society. In order to realize the goal set in the 5th Plenary Session of... Scientific and technology are the first productivity. They are the revolutionary power of accelerating the civilization progress of the human society. In order to realize the goal set in the 5th Plenary Session of the 16th Central Committee of the Communist Part of China, we must adhere to the Deng Xiaoping Theory and the guideline of Three Represents,comprehensively implement the guideline of Scientific Development,adopt the Strategy of Developing the Country wirh Science and Education and the Strategy of Talents Strengthen the Country, further exert the important role of the scientific and technology progress and innovation, so as to lead the economic and social development into the orbit of Human First and comprehensive and sustaining development.……展开更多
Based on three aesthetic criteria of logos, pathos and ethos in classic rhetoric theory, this article analyzes the modes of persuasion applied in Barack Obama's first inaugural speech. It has been found out that t...Based on three aesthetic criteria of logos, pathos and ethos in classic rhetoric theory, this article analyzes the modes of persuasion applied in Barack Obama's first inaugural speech. It has been found out that the perfect combination of these three appeals endows the speech with the rhetoric charm, passion and art of language which efficiently helps Obama to guarantee the political success in election.展开更多
According to Reiss’s Text Type theory,a key part of the functionalist approach in translation studies,the source text can be assigned to a text type and to a genre.In making this assignment,the translator can decide ...According to Reiss’s Text Type theory,a key part of the functionalist approach in translation studies,the source text can be assigned to a text type and to a genre.In making this assignment,the translator can decide on the hierarchy of postulates which has to be observed during target-text production(Mona,2005).This essay intends to conduct a linguistic and stylistic analysis of the Chinese translation of Obama’s speech to explore the general approach of the translator(if there is one),by comparing the respective results of the two analyses from the perspective of Katharina Reiss’s Text Type theory.In doing so,critical judgments will accordingly be made as to whether such an approach is justifiable or not.展开更多
This paper attempts to conduct a comparative study on Obama’s two speeches—his second inaugural address and his commencement speech in The Ohio State University in 2013 based on Halliday’s theory of Interpersonal F...This paper attempts to conduct a comparative study on Obama’s two speeches—his second inaugural address and his commencement speech in The Ohio State University in 2013 based on Halliday’s theory of Interpersonal Function.The author finds that mood,modality and personal pronouns are the major language means used to realize the interpersonal function;in his two speeches,Obama makes different choices of those resources,and different choices indicate different attitudes and intentions.展开更多
It is known to all that traditional Chinese medicine and pharmacy, as the summary of Chinese people fighting against various kinds of disease for thousands of years, has a summate theoretical system possessing the ess...It is known to all that traditional Chinese medicine and pharmacy, as the summary of Chinese people fighting against various kinds of disease for thousands of years, has a summate theoretical system possessing the essence of Chinese classical philosophy, intensively reflects deep thinking and pondering of Chinese culture on the human being himself and dialectical relation between human and culture, making indelible contribution to the offspring reproduction and prosperity.展开更多
Ladies and Gentlemen, Comrades and Friends, In this golden season of autumn, we are gathered here to mark the 70 th anniversary of the founding of the People’s Republic of China. For the Chinese people of all ethnic ...Ladies and Gentlemen, Comrades and Friends, In this golden season of autumn, we are gathered here to mark the 70 th anniversary of the founding of the People’s Republic of China. For the Chinese people of all ethnic groups and Chinese sons and daughters at home and abroad, this is a joyful moment-a moment to celebrate the 70 th birthday of our great People’s Republic and to salute the epic progress of our motherland during the past seven decades.展开更多
Ten "observances":1. We must adhere to the fundamental principles of Marxism while combining Marxism with the reality of China. We must liberalize our thoughts, be pragmatic, advance with time, update theori...Ten "observances":1. We must adhere to the fundamental principles of Marxism while combining Marxism with the reality of China. We must liberalize our thoughts, be pragmatic, advance with time, update theories according展开更多
文摘Background and Aims: On November 24, 2009, Huu S. TIEU and Golden Sunrise Pharmaceutical, Inc. (Golden Sunrise) applied for the Technology and Innovation to be reviewed and evaluated by the U.S. Food and Drug Administration (FDA). In the review and evaluation, it was requested by Golden Sunrise designated the new indications for this application under Serious or Life-threatening conditions or diseases. Discussions followed with the FDA, Huu S. TIEU, and Golden Sunrise for FDA approval on new products and new indications on existing new Medical Technology and Innovation. It was agreed in Year-2015 that the FDA would take the request for new indications to the United States Congress to establish into FDA regulation and law. At that time the following was the FDA Guidance—“Emergency Use of a Test Article” is exempt from prior Institutional Review Board or Advisory Committee evaluation and approval, provided that such emergency use is reported to the Institutional Review Board within five working days after use. Expedited Institutional Review Board or Advisory Committee approval is not permitted in emergency use. There has been no funding to the authors for the writing or publication of this article. Methods: It was requested by Huu S. TIEU and Golden Sunrise in documents given to the FDA to have Serious or Life-threatening conditions or diseases indication be recognized by law. On August 08, 2015, the FDA responding to this request took the documentation produced by Golden Sunrise to the United States Congress on behalf of Golden Sunrise and Huu S. TIEU. This article encompasses the FDA regulatory method as well as the discussion and results of the establishment of the FDA and the 21<sup>st</sup> Century Cures Act. Results: On December 13, 2016, H.R.34—114<sup>th</sup> United States Congress (2015-2016) 21<sup>st</sup> Century CURES Act was signed into law by President Barack H. Obama which included the Serious or Life-threatening indication to be written into the CURES Act. In summary, the 21<sup>st</sup> Century Cures Act is a landmark piece of legislation that enjoyed broad bipartisan support in United States Congress. The main goals of the Act are impactful and should transform future cancer, neurologic, and precision medicine or drug research as well as aid individuals with mental health is intended to facilitate the prompt approval of new agents and devices, clinicians should be aware of the types of data behind an approval and take this into consideration when developing illnesses and opioid dependence. However, some of the wording within the CURES Act regarding the drug and device approval process may bring pause to health care providers including pharmacists. Although this wording and implementing care plans and counseling patients. The 21<sup>st</sup> Century Cures Act was incorporated into laws and regulations by the FDA under § 3072 of the Act grants the Commissioner of Food and Drugs the authority to appoint and set the annual rate of pay for outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products.
文摘In order to promote China to take part in the activities of international standardization and improve the standardization level of China, Mr. Oliver Smoot, President of ISO, made a public speech on international standardization of the global economy at the invitation of SAC (Standardization Administration of China) on Nov. 1st.
文摘 Scientific and technology are the first productivity. They are the revolutionary power of accelerating the civilization progress of the human society. In order to realize the goal set in the 5th Plenary Session of the 16th Central Committee of the Communist Part of China, we must adhere to the Deng Xiaoping Theory and the guideline of Three Represents,comprehensively implement the guideline of Scientific Development,adopt the Strategy of Developing the Country wirh Science and Education and the Strategy of Talents Strengthen the Country, further exert the important role of the scientific and technology progress and innovation, so as to lead the economic and social development into the orbit of Human First and comprehensive and sustaining development.……
文摘Based on three aesthetic criteria of logos, pathos and ethos in classic rhetoric theory, this article analyzes the modes of persuasion applied in Barack Obama's first inaugural speech. It has been found out that the perfect combination of these three appeals endows the speech with the rhetoric charm, passion and art of language which efficiently helps Obama to guarantee the political success in election.
文摘According to Reiss’s Text Type theory,a key part of the functionalist approach in translation studies,the source text can be assigned to a text type and to a genre.In making this assignment,the translator can decide on the hierarchy of postulates which has to be observed during target-text production(Mona,2005).This essay intends to conduct a linguistic and stylistic analysis of the Chinese translation of Obama’s speech to explore the general approach of the translator(if there is one),by comparing the respective results of the two analyses from the perspective of Katharina Reiss’s Text Type theory.In doing so,critical judgments will accordingly be made as to whether such an approach is justifiable or not.
文摘This paper attempts to conduct a comparative study on Obama’s two speeches—his second inaugural address and his commencement speech in The Ohio State University in 2013 based on Halliday’s theory of Interpersonal Function.The author finds that mood,modality and personal pronouns are the major language means used to realize the interpersonal function;in his two speeches,Obama makes different choices of those resources,and different choices indicate different attitudes and intentions.
文摘It is known to all that traditional Chinese medicine and pharmacy, as the summary of Chinese people fighting against various kinds of disease for thousands of years, has a summate theoretical system possessing the essence of Chinese classical philosophy, intensively reflects deep thinking and pondering of Chinese culture on the human being himself and dialectical relation between human and culture, making indelible contribution to the offspring reproduction and prosperity.
文摘Ladies and Gentlemen, Comrades and Friends, In this golden season of autumn, we are gathered here to mark the 70 th anniversary of the founding of the People’s Republic of China. For the Chinese people of all ethnic groups and Chinese sons and daughters at home and abroad, this is a joyful moment-a moment to celebrate the 70 th birthday of our great People’s Republic and to salute the epic progress of our motherland during the past seven decades.
文摘Ten "observances":1. We must adhere to the fundamental principles of Marxism while combining Marxism with the reality of China. We must liberalize our thoughts, be pragmatic, advance with time, update theories according