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Management: Food and Drug Administration (FDA)
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Total 5166 results found since Jan 2013.
Personalized medicine and Hispanic health: improving health outcomes and reducing health disparities – a National Heart, Lung, and Blood Institute workshop report
AbstractPersons of Hispanic/Latino descent may represent different ancestries, ethnic and cultural groups and countries of birth. In the U.S., the Hispanic/Latino population is projected to constitute 29% of the population by 2060. A personalized approach focusing on individual variability in genetics, environment, lifestyle and socioeconomic determinants of health may advance the understanding of some of the major factors contributing to the health disparities experienced by Hispanics/Latinos and other groups in the U.S., thus leading to new strategies that improve health care outcomes. However, there are major gaps in ou...
Source: BMC Proceedings - October 3, 2017 Category: Biomedical Science Source Type: research
FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new information.
Source: FDA Center for Drug Evaluation and Research - What's New - November 15, 2017 Category: Drugs & Pharmacology Source Type: news
The FDA Is Cracking Down on Imodium and Other Anti-Diarrhea Medicine Because of the Opioid Epidemic
(WASHINGTON) — U.S. health regulators on Tuesday asked makers of popular anti-diarrhea drugs to sell their medications in smaller amounts to make them harder to abuse.
The request comes amid a spike in overdoses from large doses of the over-the-counter drugs, which contain a small amount of an opioid.
The Food and Drug Administration wants manufacturers to package their medications in smaller quantities, such as eight tablets per package. Currently, some generic versions are sold in boxes of up to 200 tablets. The FDA said it also plans to ask online retailers to make it harder to order bulk amounts of the drugs.
Th...
Source: TIME: Health - January 31, 2018 Category: Consumer Health News Authors: Matthew Perrone / AP Tags: Uncategorized onetime opioids Source Type: news
Consumer sleep technology is no substitute for medical evaluation
(American Academy of Sleep Medicine) According to a position statement from the American Academy of Sleep Medicine (AASM), consumer sleep technology must be cleared by the Food and Drug Administration (FDA) and rigorously tested if it is intended to diagnose or treat sleep disorders.
Source: EurekAlert! - Medicine and Health - May 14, 2018 Category: International Medicine & Public Health Source Type: news
Recent updates and challenges on the regulation of precision medicine: The United States in perspective
Publication date: July 2018 Source:Regulatory Toxicology and Pharmacology, Volume 96 Author(s): Lin-Chau Chang, Thomas E. Colonna The rapid progress in “omics”, such as genomics, metabolomics, microbiomics, has paved the path for precision medicine and revolutionized the development of drugs and devices promising to meet unmet medical needs. The aim of the present study was to investigate the current regulatory framework established by the United States Food and Drug Administration (USFDA) and to identify challenges and concerns through study of related literatures in the PubMed database. We found that efforts were ma...
Source: Regulatory Toxicology and Pharmacology - May 17, 2018 Category: Toxicology Source Type: research
Challenges in the Regulation of Autologous Stem Cell Interventions in the United States.
Abstract
The direct-to-consumer marketing of stem cells for unproven therapeutic uses has grown rapidly in the United States in recent years. This development is surprising since the marketing and distribution of human cell-based medical products is stringently regulated in the US. This essay describes ambiguities, gaps, and inconsistencies in the current regulatory system that have enabled such businesses to thrive. In addition to directly challenging the authority of the Food and Drug Administration (FDA) over autologous cell-based products in the courts, stem cell marketing firms have also identified and exploi...
Source: Perspectives in Biology and Medicine - June 1, 2018 Category: Medical Ethics Authors: Sipp D Tags: Perspect Biol Med Source Type: research
How Should the FDA Review Diagnostic Radiopharmaceuticals?
The purpose of this article is to reconsider the manner in which the U.S. Food and Drug Administration (FDA) reviews diagnostic radiopharmaceuticals. Mass characteristics of several common nonradioactive drugs and several diagnostic radiopharmaceuticals are considered. A history of the regulation of radiopharmaceuticals is presented. The Society of Nuclear Medicine and Molecular Imaging and the American College of Nuclear Medicine should choose the membership of a radiopharmaceutical advisory committee, and the FDA should contract with them to do so. Members of the radiopharmaceutical advisory committee should decide on th...
Source: Journal of Nuclear Medicine - June 1, 2018 Category: Nuclear Medicine Authors: Marcus, C. S. Tags: Issues and Controversies Source Type: research
Updating professional development for medical librarians to improve our evidence-based medicine and information literacy instruction.
Authors: Costello J
Abstract
Medical librarians lack professional development opportunities in the critical appraisal of biomedical evidence. An update to our professional development opportunities could support our efforts to teach critical appraisal of biomedical evidence during evidence-based medicine or information literacy instruction. If we enhance our understanding of latent influences on evidence quality-such as changes to Food and Drug Administration regulations, predatory or deceptive publishing practices, and clinical trial study designs-we can improve our value to medical education and hospital systems....
Source: Journal of the Medical Library Association : JMLA - July 4, 2018 Category: Databases & Libraries Tags: J Med Libr Assoc Source Type: research
3 Companies Recall Blood Pressure Medications Over Cancer Fears
Some drugs used to control high blood pressure and prevent heart failure were voluntarily recalled this past week due to an impurity that could possibly lead to cancer, the U.S. Food and Drug Administration said.
These products — with the active ingredient valsartan, a generic drug used to treat high blood pressure — may contain N-nitrosodimethylamine (NDMA), a possible human carcinogen. The FDA asked three companies, Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd., to recall their valsartan products. Solco and Teva were also asked to recall their drugs containing valsartan/hydr...
Source: TIME: Health - July 17, 2018 Category: Consumer Health News Authors: Jennifer Calfas Tags: Uncategorized medicine onetime Source Type: news
Nuclear Medicine Therapy With 223Radium-dichloride for Osseous Metastases in Prostate Carcinoma.
Abstract
Painful osseous metastasis resulting from castration-resistant prostate carcinoma is a common clinical problem. Historically, nuclear medicine offered several palliative beta-emitting radiopharmaceuticals targeting the skeleton with the goal of decreasing pain. However, these have largely been replaced by the alpha-emitting agent radium (Ra). Ra received Food and Drug Administration approval in 2013 for the treatment of metastatic castration-resistant prostate cancer with symptomatic bone metastases without visceral metastases. Ra offers an improved therapeutic profile due to its alpha-particle emissions ...
Source: Clinical Prostate Cancer - September 10, 2018 Category: Cancer & Oncology Authors: Wale DJ, Viglianti BL, Gross MD, Ferretti A, Rubello D, Wong KK Tags: Am J Clin Oncol Source Type: research
Penn researchers receive $18 million grant for Tobacco Center of Regulatory Science
(University of Pennsylvania School of Medicine) A new $18 million grant to Penn Medicine researchers will allow them to take aim at the effects of tobacco marketing. The U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) have renewed their commitment to the Tobacco Centers of Regulatory Science (TCORS) program and awarded a second cohort (TCORS 2.0) of centers.
Source: EurekAlert! - Medicine and Health - September 18, 2018 Category: International Medicine & Public Health Source Type: news
New IQVIA data show medicine prices grew just 1.5 percent in 2018
Last year, the U.S. Food and Drug Administration approved a record of 59 novel new medicines. During this incredible era of innovation, medicine prices grew just 1.5 percent in 2018, after factoring in negotiated rebates and discounts, according to anew report from the IQVIA Institute for Human Data Science, “The Global Use of Medicine in 2019 and Outlook to 2023.”
Source: The Catalyst - January 29, 2019 Category: Pharmaceuticals Tags: Let's Talk About Cost Source Type: news
FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new information.
Source: FDA Center for Drug Evaluation and Research - What's New - August 22, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Adverse Events of Novel Therapies for Hematologic Malignancies: What Emergency Physicians Should Know
Publication date: Available online 24 September 2019Source: Annals of Emergency MedicineAuthor(s): Mohsin Shah, Eva Rajha, Courtney DiNardo, Erin Muckey, William G. Wierda, Sai-Ching J. YeungIn the past decade, rapid advances in therapeutic target discovery in hematologic malignancies have led to many clinical studies demonstrating efficacy of novel agents. Between 2014 and 2018, Food and Drug Administration approvals of new drugs and agents have increased, with greater than 2 dozen novel agents. Rapidly identifying the risk profiles of these cancer therapeutics that may present with acute toxicities and understanding the ...
Source: Annals of Emergency Medicine - September 25, 2019 Category: Emergency Medicine Source Type: research
Scientists Designed a Drug for Just One Patient. Her Name Is Mila.
An achievement in ultra-personalized medicine also raises questions about fairness and regulation.
Source: NYT Health - October 10, 2019 Category: Consumer Health News Authors: Gina Kolata Tags: Drugs (Pharmaceuticals) Genetics and Heredity Disabilities Ataxia-Telangiectasia (Genetic Disease) Medicine and Health Children and Childhood Boston Children ' s Hospital Food and Drug Administration New England Journal of Medicine B Source Type: news
