Three Years After Enactment of the Drug Quality and Security Act
FDA’s compounding program aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them. Here you can find informations to laws &policies, compliance action, ....
You don't always need antibiotics when you're sick—only for infections caused by bacteria. And overuse is causing a global health problem.
Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epi...demic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO will expedite prequalification and licensing of the vaccine for use in countries at risk of Ebola outbreaks and will coordinate work between those countries’ regulatory authorities and the European Medicines Agency and the US Food and Drug Administration.
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Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health. Submitted to the United Nations Children’s Fund by JSI, Arlington, VA: JSI Research & Training Institute, Inc....
This guide will assist program managers, service providers, and technical experts when conducting a quantification of commodity needs for the 13 reproductive, maternal, newborn, and child health commodities prioritized by the UN Commission on Life-Saving Commodities for Women and Children. This quantification supplement should be used with the main guide—Quantification of Health Commodities: A Guide to Forecasting and Supply Planning for Procurement. * This supplement describes the steps in forecasting consumption of these supplies when consumption and service data are not available; after which, to complete the quantification, the users should refer to the main quantification guide for the supply planning step.
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The "Cystic Fibrosis Fact Sheet" by the National Heart, Lung, and Blood Institute provides an overview of cystic fibrosis (CF), a chronic and often fatal genetic disorder affecting the respiratory and digestive systems. The document outlines the causes, genetic inheritance patterns, and symptoms of ...CF, which include thick mucus buildup, respiratory issues, and digestive problems. It also discusses diagnostic methods, such as the sweat test and genetic testing, and highlights current treatment approaches focused on symptom management, including chest therapy, medications, and potential gene therapy. The fact sheet emphasizes patient and family education to improve quality of life and support coping strategies.
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The National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), 2020-2025, presents
coordinated, strategic actions that the United States Government will take in the next five years to improve the health and wellbeing of all Americans by changing the course of antibiotic resistance.
T...his Plan is based on the U.S. Government’s 2014 National Strategy for CARB, and builds on the first National Action Plan released in 2015 by expanding evidence-based activities that have already been shown to reduce antibiotic resistance, such as optimizing the use of antibiotics in human and animal health settings.
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Comprehensive Reviews in Food Science and Food Safety, Vol.12 (2013) pp.234-248
In 2006, the Institute of Food Technologists (IFT) published an Expert Report entitled “Antimicrobial Resistance: Implications for the Food System” (IFT 2006). That report summarized current scientific knowledge pe...rtaining to the public-health impact of antimicrobial use in the food system and the development and control of antimicrobial resistance. Since that time, intense interest in this topic has continued within the regulatory and scientific communities as well as the general public. This IFT Scientific Status Summary serves to update that 2006 IFT Expert Report by briefly reviewing new scientific evidence relevant to the goals of the initial report and providing a number of key observations and conclusions.
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3 March 2022
The WHO Therapeutics and COVID-19: living guideline contains the Organization’s most up-to-date recommendations for the use of therapeutics in the treatment of COVID-19. The latest version of this living guideline is available in pdf format (via the ‘Download’ button) and via an ...online platform, and is updated regularly as new evidence emerges.
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English Manual and Guideline on World about Food and Nutrition, Health and Epidemic; published on 30 Nov 2021 by USAID
FEY ENFOMASYON POU MOUN K’AP RESEVWA AVEK MOUN K’AP BAY SWEN OTORIZASYON POU ITILIZASYON IJANS (EUA) POU VAKSIN MODERNA COVID-19 POU ANPECHE CORONAVIRUSDISEASE 2019
(COVID-19) NAN PERSONN 18 ANE AK PI GRAN
sthma prevalence is increasing worldwide, and surveys indicate that most patients in developed and developing countries, including South Africa, do not receive optimal care and are therefore not well controlled. Standard management guidelines adapted to in-country realities are important to support ...optimal care. The South African Thoracic Society (SATS) first published a guideline for the management of chronic persistent asthma in 1992, which has subsequently been revised several times.
The main aim of the present document was to revise and update SATS’ statement on the suggested management of chronic asthma, based on the need to promote optimal care and control of asthma, together with the incorporation of new concepts and drug developments. This revised document reinforces optimal care and incorporates the following primary objectives to achieve the recent advances in asthma care:
• continued emphasis on the use of inhaled corticosteroids (ICS) as the foundation of asthma treatment
• to reduce the reliance on short-acting beta-2 agonist (SABA) monotherapy for asthma symptoms
• to incorporate the evidence and strategy for the use of the combination of an ICS and formoterol for acute symptom relief (instead of a SABA)
• to incorporate the evidence and strategy for the use of as-needed ICS-long-acting beta agonists (LABA) for patients with infrequent symptoms or ‘mild’ asthma
• to incorporate the evidence and strategy for the use of a long-acting muscarinic antagonist (LAMA) in combination with ICS-LABA; and
• to incorporate the evidence and strategy for the use of and management with a biologic therapy in severe asthma.
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Handbook of Foodborne Pathogenic Microorganisms and Natural Toxins
This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita...ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
The Operational guide: use of referral laboratories for the analysis of foodborne hazards in the Pacific aims to strengthen the food analysis capacity of Pacific Island countries and areas by identifying national and reference laboratories capable of testing for priority foodborne hazards. The Pacif...ic Island countries and areas are often vulnerable to food safety incidents and emergencies due to their geographical distribution and dependence on food imports. The guide outlines key considerations for selecting referral laboratories and submitting samples to them, enabling continuous improvement of food safety systems and providing safe food for all. The target audiences are health and food safety authorities.
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Scientists have known for more than half a century that patients could develop resistance to the drugs used to treat them. Alexander Fleming, who is credited with creating the first antibiotic, penicillin, in 1928, cautioned of the impending crisis while accepting his Nobel prize in 1945: “There ...is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.” Since then antibiotics have proved one of the most effective interventions in human medicine. Sadly, the overuse and misuse of this precious resource have brought us to a global crisis of antimicrobial resistance (AMR). To address this crisis nearly seven decades after Fleming’s lecture the first UN general assembly meeting on drug resistance bacteria was convened in September 2017.
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