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, ....
Three Years After Enactment of the Drug Quality and Security Act
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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English Manual and Guideline on World about Food and Nutrition, Health and Epidemic; published on 30 Nov 2021 by USAID
Handbook of Foodborne Pathogenic Microorganisms and Natural Toxins
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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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.
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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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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Includes a Special Report on the Financial and Personal Benefits of Early Diagnosis
2018 Alzheimer’s Disease Facts and Figures is a statistical resource for U.S. data related to Alzheimer’s disease,
the most common cause of dementia. Background and context for interpretating the data are con...tained in
the Overview. Additional sections address prevalence, mortality and morbidity, caregiving and use and costs of health care and services. A Special Report discusses the financial and personal benefits of diagnosing earlier in the disease process, in the stage of mild cognitive impairment.
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The Healthy Living Toolkit is developed to educate refugees, immigrants, resettlement agencies, clinics, community based organizations, and other service providers on refugee health issues. The toolkit presents material in a culturally appropriate manner and is intended to help health care-related p...rofessionals more effectively assist refugees and immigrants and reduce health disparities among these populations. The toolkit is available in multiple languages
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PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laborato...ry – the two key institutions to ensure the quality, safety, and efficacy of medicines. The MOH Pharmacy Taskforce (PTF) is to be commended however for successfully controlling the pharmaceutical market to the extent that there is no informal medicines market in Rwanda. Based on its findings, the assessment team expects Rwanda to be able to make great strides in evidence-based medicines quality assurance in the short to medium term, provided it receives adequate technical assistance and financial support.
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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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