Safety assessment for octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate (CAS Reg. No. 2082-79-3) from use in food contact applications

Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate (CAS Reg. No. 2082-79-3), currently marketed as Irganox 1076 (I-76), is a sterically hindered phenolic antioxidant used in a variety of organic substrates, including those used in the manufacture of food contact articles. In 2012, the US Food and Drug Administration (USFDA), Office of Food Additive Safety (OFAS), initiated a post-market re-evaluation of the food contact applications of I-76. This project aimed to ensure that current dietary exposures from the use of I-76 in food contact articles are accurately captured and the safety assessment considered all relevant and available toxicological information. To accomplish these aims, the USFDA reviewed the available toxicological studies and chemistry information on food contact applications of I-76. Based on this in-depth analysis, a NOAEL of 64 mg/kg-bw/d (female rats) from a chronic rat study and a cumulative estimated dietary intake (CEDI) of 4.5 mg/p/d, was used to calculate a margin of exposure (MOE) of ∼850. We concluded that the previous and current exposure levels provide an adequate margin of safety (MOS) and remain protective of human health for the regulated uses.     

美国FDA在应急医药产品应急准备中的职能分析

目的:对美国流行病和灾害性应急准备系列法案中美国食品药品监督管理局(FDA)职能定位进行分析,为我国政府部门的应急职能设计提供参考。方法:采取法案内容分析法,了解FDA在应急医药产品准备中的职能定位。结果:FDA在医药产品应急准备的根本职能是促进突发事件中应急医药产品的开发和使用的可获得性,包括发布医药产品的应急指导和安全警示信息,负责授权医药产品紧急使用权、延长医药产品保存期限及预置职能。结论:应重视国家级应急准备工作,完善应急准备的配套法律体系,准确定位"应急医药产品的应急预案",加强应急医药产品的应急信息化管理,建设应急医药产品的快速调剂和使用机制。     

Cardiac resynchronization devices: the Food and Drug Administration's regulatory considerations

Cardiac resynchronization therapy (CRT) devices have been studied clinically since 1998, and have been on the U.S. market since the Food and Drug Administration (FDA) approval of the first product in 2001. Since that time, the FDA has approved many different models from three different manufacturers, representing the first and second generations of these products. All of these products have undergone the FDA pre-market approval process, which examines the safety and effectiveness of the devices for their intended use. Over the last several years, the FDA has adapted recommendations for CRT clinical trials based on an evolving understanding of what these devices can achieve. This paper will outline the dynamic nature of the FDA's approval process for CRT devices and briefly review the clinical trial designs for the first generation devices.     

FDA“医院获得性细菌性肺炎和呼吸机相关性细菌性肺炎：供企业用治疗药物开发指导原则”介绍

美国食品药品监督管理局（FDA）于2020年6月发布了“医院获得性细菌性肺炎和呼吸机相关性细菌性肺炎：供企业用治疗药物开发指导原则”。该指导原则阐述了治疗这类疾病的抗菌药物临床研究的一般原则和具体试验设计的建议。介绍该指导原则的主要内容,期待对中国“医院获得性细菌性肺炎/呼吸机相关细菌性肺炎抗菌药物临床试验技术指导原则（征求意见稿）”的定稿和促进这类药物的研究有帮助。     

B cell elimination in systemic lupus erythematosus

Systemic lupus erythematosus (SLE) is an autoimmune disorder with a worldwide distribution, potentially life-threatening with considerable morbidity. The elimination of pathogenic B cells has emerged as a rational therapeutic option. Many open label studies have reported encouraging results in which clinical and serological remission have invariably been described, often enabling the reduction of steroid and immunosuppressive treatment. However, the results from randomized controlled studies have been disappointing and several questions remain to be answered. In this review we will focus on results of B cell direct depletion in the treatment of patients with systemic lupus erythematosus.     

2019年美国FDA批准上市的新药简介

2019年美国食品药品监督管理局(FDA)批准上市新药48个,其中化学小分子38个、生物制品10个。本文根据FDA批准的新药说明书以及相关文献和专利情况,简要介绍化学小分子药物的概况、适应证、作用机制、剂型规格、不良反应和合成路线等,以及生物制品的相关情况。     

N-Terminal Pro–B-Type Natriuretic Peptide in the Emergency Department: The ICON-RELOADED Study

Background

Contemporary reconsideration of diagnostic N-terminal pro–B-type natriuretic peptide (NT-proBNP) cutoffs for diagnosis of heart failure (HF) is needed.

American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis

This literature review and the recommendations herein were prepared for the American Gastroenterological Association Clinical Practice Committee. The paper was approved by the Committee on May 16, 2004, and by the AGA Governing Board on September 23, 2004.     

Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs

Background

Concerns exist that women are underrepresented in trials of cardiovascular medications.