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
The important role of atherosclerosis in pathophysiology of Alzheimer's Disease has become evident.Mechanisms such as hyperlipidemia,inflammation,abdominal obesity and insulin resistance are important yet they may...The important role of atherosclerosis in pathophysiology of Alzheimer's Disease has become evident.Mechanisms such as hyperlipidemia,inflammation,abdominal obesity and insulin resistance are important yet they may not fully explain the specific involvement of the Circle of Willis in these pathologies.The Circle of Wills is a complex geometrical structure which has several areas with different curvature as well as various branching angles of vessels composing the circle.The hemodynamics in this region should take into account the Dean number which indicates the influence of curvature on the resistance to blood flow.Thus,areas with various curvature and angles may have different hemodynamics and there are certain areas in the Circle of Willis that are more likely to develop atherosclerotic changes.Therefore,this could suggest the novel pathophysiological pathway resulting from the geometric peculiarities of the Circle of Willis.One of the directions of future research is to examine whether specific areas of the Circle of Willis are more likely to develop atherosclerotic changes compared to other ones.Selective areas of the Circle of Willis affected by atherosclerotic changes could indicate the primary role of atherosclerosis promoting Alzheimer's disease although other pathophysiological mechanisms suggesting the opposite direction should be also examined in prospective studies.展开更多
This study introduces three typical models on equilibrium beach profile, and discusses the application limitations of these models. Then this study examines the selections for applying these models on different coasta...This study introduces three typical models on equilibrium beach profile, and discusses the application limitations of these models. Then this study examines the selections for applying these models on different coastal segments of a headland-bay beach in west Guangdong, South China, and explores the physical significances of those parameters in the models. The results indicate that：（1） Bodge＇s model is more in line with the equilibrium beach profile of the tangential or transitional segment, whereas Lee＇s model is more consistent with the shadow profile;（2） most of the parameters in three models have clear physical significances in accordance with the actual characteristics of this headland-bay beach; and（3） both the selections for the equilibrium beach profile from different segments and significances of most of the parameters in three models are in essence correlated with the morphodynamic states at various coastal locations.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The important role of atherosclerosis in pathophysiology of Alzheimer's Disease has become evident.Mechanisms such as hyperlipidemia,inflammation,abdominal obesity and insulin resistance are important yet they may not fully explain the specific involvement of the Circle of Willis in these pathologies.The Circle of Wills is a complex geometrical structure which has several areas with different curvature as well as various branching angles of vessels composing the circle.The hemodynamics in this region should take into account the Dean number which indicates the influence of curvature on the resistance to blood flow.Thus,areas with various curvature and angles may have different hemodynamics and there are certain areas in the Circle of Willis that are more likely to develop atherosclerotic changes.Therefore,this could suggest the novel pathophysiological pathway resulting from the geometric peculiarities of the Circle of Willis.One of the directions of future research is to examine whether specific areas of the Circle of Willis are more likely to develop atherosclerotic changes compared to other ones.Selective areas of the Circle of Willis affected by atherosclerotic changes could indicate the primary role of atherosclerosis promoting Alzheimer's disease although other pathophysiological mechanisms suggesting the opposite direction should be also examined in prospective studies.
基金financially supported by the National Natural Science Foundation of China(Grant No.41301005)Postdoctoral Science Foundation of China(Grant No.2014M552118)
文摘This study introduces three typical models on equilibrium beach profile, and discusses the application limitations of these models. Then this study examines the selections for applying these models on different coastal segments of a headland-bay beach in west Guangdong, South China, and explores the physical significances of those parameters in the models. The results indicate that：（1） Bodge＇s model is more in line with the equilibrium beach profile of the tangential or transitional segment, whereas Lee＇s model is more consistent with the shadow profile;（2） most of the parameters in three models have clear physical significances in accordance with the actual characteristics of this headland-bay beach; and（3） both the selections for the equilibrium beach profile from different segments and significances of most of the parameters in three models are in essence correlated with the morphodynamic states at various coastal locations.
