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Administrative Law

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https://www.readbyqxmd.com/read/29141490/study-on-enhanced-lymphatic-tracing-of-isosulfan-blue-injection-by-influence-of-osmotic-pressure-on-lymphatic-exposure
#1
Tiantian Ye, Rui He, Yue Wu, Lei Shang, Shujun Wang
Isosulfan blue (IB) is being used as a lymphatic tracer has been approved by the FDA in 1981. This study aimed at improving lymphatic exposure of IB injection by osmotic pressure regulation to achieve step-by step lymphatic tracing. First, IB injection with appropriate osmotic pressure, stability and suitable pH was prepared. Next, the lymphatic tracing ability of different osmotic pressure was studied to determine the blue-stained state of IB in three-level lymph nodes after subcutaneous administration. Furthermore, pharmacokinetics of lymphatic drainage, lymph node uptake and plasma concentration was investigate to explore the improving law of the lymphatic tracing by osmotic pressure, and combined with tissue irritation to determine the optimal osmotic pressure...
November 15, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/29140654/proposed-industry-best-practices-in-development-and-marketing-of-medical-foods-for-the-management-of-chronic-conditions-and-diseases-while-awaiting-regulation
#2
Bruce Burnett, Robert M Levy
Ideal therapeutics have low toxicity and can effectively manage condition(s) or disease(s). The Food & Drug Administration (FDA) marketing category of therapeutics called “medical foods” (MFs) meets such a definition. Medical foods have existed in Federal law since passage the Orphan Drug Act in 1988, which created a category of nutritional therapeutics separate from drugs. Unfortunately, MFs are not widely understood by the medical community or utilized in all patients who need them due to lack of a FDA-approval process, unclear and contradictory guidance especially with regard for need for an investigational new drug (IND) application, and no clear regulations regarding their development and marketing...
2017: Food and Drug Law Journal
https://www.readbyqxmd.com/read/29139306/equilibria-kinetics-and-mechanism-for-the-degradation-of-the-cytotoxic-compound-l-n-g-nitroarginine
#3
Pham Van Quyet, Bernice Mei Jin Tan, Celine Valeria Liew, Lai Wah Chan, Quan Sing Ng, Paul Wan Sia Heng
L-N(G)-nitroarginine (LNNA), an analogue of L-arginine, is a competitive inhibitor of nitric oxide synthase which causes the selective reduction of blood flow to tumor cells. Despite the potential of LNNA to function as an adjuvant in cancer therapies, its poor solubility and stability have hindered the development of an injectable formulation of LNNA that is suitable for human administration. This work, for the first time, details a systematic study on the determination of equilibrium Ka constants and the rate law of LNNA degradation...
November 15, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/29121177/out-of-pocket-and-health-care-spending-changes-for-patients-using-orally-administered-anticancer-therapy-after-adoption-of-state-parity-laws
#4
Stacie B Dusetzina, Haiden A Huskamp, Aaron N Winn, Ethan Basch, Nancy L Keating
Importance: Oral anticancer medications are increasingly important but costly treatment options for patients with cancer. By early 2017, 43 states and Washington, DC, had passed laws to ensure patients with private insurance enrolled in fully insured health plans pay no more for anticancer medications administered by mouth than anticancer medications administered by infusion. Federal legislation regarding this issue is currently pending. Despite their rapid acceptance, the changes associated with state adoption of oral chemotherapy parity laws have not been described...
November 9, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/29119293/asparaginase-erwinia-chrysanthemi-effectively-depletes-plasma-glutamine-in-adult-patients-with-relapsed-refractory-acute-myeloid-leukemia
#5
Ashkan Emadi, Jennie Y Law, Erin T Strovel, Rena G Lapidus, Linda J B Jeng, Myounghee Lee, Miriam G Blitzer, Brandon A Carter-Cooper, Danielle Sewell, Isabella Van Der Merwe, Sunita Philip, Mohammad Imran, Stephen L Yu, Hongxia Li, Philip C Amrein, Vu H Duong, Edward A Sausville, Maria R Baer, Amir T Fathi, Zeba Singh, Søren M Bentzen
Depletion of glutamine (Gln) has emerged as a potential therapeutic approach in the treatment of acute myeloid leukemia (AML), as neoplastic cells require Gln for synthesis of cellular components essential for survival. Asparaginases deplete Gln, and asparaginase derived from Erwinia chrysanthemi (Erwinaze) appears to have the greatest glutaminase activity of the available asparaginases. In this Phase I study, we sought to determine the dose of Erwinaze that safely and effectively depletes plasma Gln levels to ≤ 120 μmol/L in patients with relapsed or refractory (R/R) AML...
November 8, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29112651/progesterone-for-prevention-of-preterm-birth-shortcomings-and-unintended-consequences-of-the-orphan-drug-act
#6
Rebekah E Gee, SreyRam Kuy, Laura O Karas
Preterm birth is a problem of major public health significance that continues to plague our country despite the existence of a therapy, 17α-hydroxyprogesterone caproate, with known efficacy in reducing the risk of spontaneous preterm birth among high-risk women. Over the past several years, the Louisiana Department of Health has undertaken a robust, multifaceted initiative to improve access to 17α-hydroxyprogesterone caproate, which resulted in a 3.5-fold increase in the percentage of eligible high-risk pregnant women in the Medicaid program who received the therapy between 2013 and 2016...
November 3, 2017: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/29106296/what-is-recklessness-in-scientific-research-the-frank-sauer-case
#7
David B Resnik, Elise M Smith, Stefanie H Chen, Carlos Goller
On May 22, 2017, administrative law Judge Leslie Rogall of the Department of Health and Human Services' Departmental Appeals Board, Civil Remedies Division, ruled in favor of the Office of Research Integrity (ORI) concerning its decision to charge former University of California at Riverside biochemistry professor Frank Sauer with research misconduct for fabricating or falsifying digital image data included in three papers and seven grant applications submitted to the National Institutes of Health. More specifically, Sauer was deemed responsible for manipulating, reusing, and falsely labeling images of autoradiograms and gels in his research in epigenetics...
2017: Accountability in Research
https://www.readbyqxmd.com/read/29103409/40th-birthday-of-the-italian-mental-health-law-180-perception-and-reputation-abroad-and-a-personal-suggestion
#8
T Becker, H Fangerau
How things are perceived from a distance may help better understand their nature. Perceptions at home are likely to shape perceptions abroad. The mutual cross-references between local and distant perspectives on the Italian Mental Health Law 180 may help understand the process which preceded and resulted in the reform. This editorial argues that Law 180 came about at a unique - enabling - time in history. It argues that the run-up to and passing of Law 180 constituted a great accomplishment by professionals, the wider public and politicians/administrators...
November 6, 2017: Epidemiology and Psychiatric Sciences
https://www.readbyqxmd.com/read/29096914/the-medical-incapacity-hold-a-policy-on-the-involuntary-medical-hospitalization-of-patients-who-lack-decisional-capacity
#9
Erick H Cheung, Jonathan Heldt, Thomas Strouse, Paul Schneider
BACKGROUND: Medically hospitalized patients who lack decisional capacity may request, demand, or attempt to leave the hospital despite grave risk to themselves. The treating physician in this scenario must determine how to safeguard such patients, including whether to attempt to keep them in the hospital. However, in many jurisdictions, there are no laws that address this matter directly. In this absence, psychiatrists are often called upon to issue an involuntary psychiatric hold (civil commitment) to keep the patient from leaving...
September 21, 2017: Psychosomatics
https://www.readbyqxmd.com/read/29091355/-the-history-of-the-decree-on-the-department-of-ambulatory-care-and-community-medicine
#10
Taline Garibian
In 1957 the Grand Council of Vaud adopted a decree aiming to clarify the administrative situation of the Department of ambulatory care and community medicine created in 1887 under the name of central dispensary. The new decree confirms the special status of the Department of ambulatory care and community medicine, which becomes a public-law institution. This article reviews the context and the stakes of this legal evolution.
November 1, 2017: Revue Médicale Suisse
https://www.readbyqxmd.com/read/29089089/-long-and-short-stays-under-asppi-comparison-of-clinical-and-non-clinical-data-from-250-initial-certificates
#11
A Michel, N Alamowitch, R Gourevitch
BACKGROUND: On July 5, 2011, France introduced a law permitting the involuntary admission of patients considered to be in "imminent danger" into psychiatric care without the consent of the family. This is known as "admission en soins psychiatriques pour péril imminent"(ASPPI). ASPPI authorizes all physicians to hospitalize a patient without his or her consent nor the consent of a third party. This differs from previous measures as only one certificate is needed. The law also requires involuntarily admitted patients to present themselves before a judge specialized in Liberties and Detentions (juge des libertés et des détentions), 12 days following their admission...
October 28, 2017: L'Encéphale
https://www.readbyqxmd.com/read/29082350/gene-editing-interpretation-of-current-law-and-legal-policy
#12
Na-Kyoung Kim
With the development of the third-generation gene scissors, CRISPR-Cas9, concerns are being raised about ethical and social repercussions of the new gene-editing technology. In this situation, this article explores the legislation and interpretation of the positive laws in South Korea. The BioAct does not specify and regulate 'gene editing' itself. However, assuming that genetic editing is used in the process of research and treatment, we can look to the specific details of the regulations for research on humans as well as gene therapy research in order to see how genetic editing is regulated under the BioAct...
September 2017: Balsaeng'gwa Saengsig
https://www.readbyqxmd.com/read/29077986/the-morality-of-health-care-reform-liberal-and-conservative-views-and-the-space-between-them
#13
Timothy Stoltzfus Jost
We have just completed an exhausting nine-month debate on the future of the Affordable Care Act. I see this debate as having ended-as of this writing-in a draw. After months of repeal efforts, Republicans in the House barely passed in early May, with a 217-to-213 margin, the American Health Care Act, which would have significantly amended the ACA. Republicans in the Senate spent the summer trying to arrive at amendments to the AHCA that could attract fifty of their fifty-two votes, but in the end, the clock ran out on their opportunity to enact an amendment without Democratic input...
October 27, 2017: Hastings Center Report
https://www.readbyqxmd.com/read/29076063/neuropsychiatric-events-associated-with-leukotriene-modifying-agents-a-systematic-review
#14
REVIEW
Sharon W Y Law, Angel Y S Wong, Shweta Anand, Ian C K Wong, Esther W Chan
INTRODUCTION: Leukotriene-modifying agents (LTMAs) including montelukast, zafirlukast, and zileuton are approved by the US Food and Drug Administration (FDA) for the treatment of asthma and allergic rhinitis. Various neuropsychiatric events (NEs) have been reported; however, the evidence of the association is conflicting. This systematic review investigates the association between NEs and LTMAs by assessing the relevant published literature. METHODS: PubMed, EMBASE, MEDLINE, and Cochrane Library were searched using keywords...
October 26, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29076039/effect-of-trelagliptin-on-quality-of-life-in-patients-with-type-2-diabetes-mellitus-study-protocol
#15
Hitoshi Ishii, Yuki Suzaki, Yuko Miyata
INTRODUCTION: Long-term glycemic control in type 2 diabetes is critical to prevent or delay the onset of macrovascular and microvascular complications. Medication adherence is an integral component of type 2 diabetes management. Minimizing the dosing frequency of antidiabetic drugs may reduce treatment burden for patients and improve medication adherence. This study has been proposed to assess the reduction in treatment burden during 12 weeks' administration of trelagliptin, a weekly dosing dipeptidyl peptidase-4 (DPP-4) inhibitor, compared with a daily dosing DPP-4 inhibitor in patients with type 2 diabetes...
October 26, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29074515/euthanasia-and-physician-assisted-suicide-not-meeting-due-care-criteria-in-the-netherlands-a-qualitative-review-of-review-committee-judgements
#16
David Gibbes Miller, Scott Y H Kim
ObjectivesTo assess how Dutch regional euthanasia review committees (RTE) apply the euthanasia and physician-assisted suicide (EAS) due care criteria in cases where the criteria are judged not to have been met ('due care not met' (DCNM)) and to evaluate how the criteria function to set limits in Dutch EAS practice. DESIGN: A qualitative review using directed content analysis of DCNM cases in the Netherlands from 2012 to 2016 published on the RTE website (https://www.euthanasiecommissie...
October 25, 2017: BMJ Open
https://www.readbyqxmd.com/read/29073989/drug-policy-in-the-czech-republic
#17
Jana Skoupá
BACKGROUND: The legal background of the current pharmaceutical pricing and reimbursement (P&R) setting in the Czech Republic is based on Act 48/1997. Since 2008, the P&R process has been coordinated by the State Institute for Drug Control, which is the main stakeholder in the decision-making process; marketing authorization holders and insurance funds (IFs) also participate. OBJECTIVES: To present a general overview of the current Czech health care system and its P&R principles...
September 2017: Value in Health Regional Issues
https://www.readbyqxmd.com/read/29071571/perceptions-of-ethical-climate-and-research-pressures-in-different-faculties-of-a-university-cross-sectional-study-at-the-university-of-split-croatia
#18
Mario Malički, Vedran Katavić, Domagoj Marković, Matko Marušić, Ana Marušić
We determined the prevailing ethical climate at three different schools of a single university, in order to explore possible differences in the ethical climate related to different research fields: the School of Electrical Engineering, Mechanical Engineering, and Naval Architecture; the School of Humanities and Social Sciences; and the School of Medicine. We used the Ethical Climate Questionnaire to survey the staff (teachers and administration) at the three schools, and used the research integrity and organizational climate (RIOC) survey for early-stage researchers at the three schools...
October 25, 2017: Science and Engineering Ethics
https://www.readbyqxmd.com/read/29071349/tanning-salon-compliance-rates-in-states-with-legislation-to-protect-youth-access-to-uv-tanning
#19
Melissa S Williams, Brittany Buhalog, Laura Blumenthal, Erik J Stratman
Importance: The US Food and Drug Administration has classified tanning beds as carcinogenic. Most states have enacted legislation to prevent or create barriers for minors accessing tanning establishments. Determining tanning salon compliance with legislation would provide an indication of the influence of legislation at preventing exposure to the carcinogen in minors. Objectives: To investigate compliance rates in the 42 states and the District of Columbia with legislation restricting tanning bed use in minors and to identify differences in compliance based on population, regional location, salon ownership, age group being regulated, and time since the law was enacted...
October 25, 2017: JAMA Dermatology
https://www.readbyqxmd.com/read/29064815/legal-aspects-of-counteracting-the-trafficking-of-falsified-medicines-in-the-european-union
#20
Vitalii Pashkov, Aleksey Soloviov, Andrii Olefir
INTRODUCTION: The paper identifies key risks associated with the illegal production and sale of medicines. Also there were generalized features of criminal responsibility for acts related to the trafficking of drugs in some Member States of the EU and analyzed legal means of combating the falsified drugs today. The problem concerning falsification of medicines is particularly acute not only in developing countries but also in developed ones. Fake is one in ten - twenty drug. The largest share of falsified drugs comes from the so-called «Asian tigers», already from which they come to the EU market...
2017: Wiadomości Lekarskie: Organ Polskiego Towarzystwa Lekarskiego
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